Drug Information Update - PerformRx · As a precautionary measure, Sanofi on Friday, October 18, initiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States

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Drug Information Update November 2019

Page 1 www.performrx.com 200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved

TABLE OF CONTENTS NEWLY AVAILABLE GENERICS ................................................................. 2

NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS ............................... 3

NEW INDICATIONS (EXISTING DRUGS) .................................................... 5

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 6

STUDIES AND RECENT TOPICS ............................................................... 23

RECALLS ................................................................................................ 27

CURRENT DRUG SHORTAGES ................................................................ 70


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM

GENERIC MANUFACTURER BRAND NAME

METHYLPREDNISOLONE SODIUM SUCCINATE 500 MG VIAL WEST-WARD/HIKMA SOLU-MEDROL

CIPROFLOXACIN HCL/FLUOCINOLONE

0.3%-0.025% (0.25 ML) VIAL WILSHIRE PHARMA OTOVEL

PRENATAL 147/IRON/FOLIC ACID

13 MG IRON-1 MG TABLET SOLUBIOMIX, LLC AZESCO

GADOTERATE MEGLUMINE

5 MMOL/10 ML, 7.5 MMOL/15 ML,

10 MMOL/20 ML VIAL GE HEALTHCARE DOTAREM


NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES CYSTIC FIBROSIS-

CFTR POTENTIATOR-CORRECTOR

COMBINATION

TRIKAFTA ELEXACAFTOR/ TEZACAFTOR/

IVACAFTOR

100 MG-50 MG-75 MG (DAY)/150 MG

(NIGHT) TABLET NEW ENTITY

TOPICAL ANTI-INFLAMMATORY,

NSAIDS DIMENTHO DICLOFENAC/

MENTHOL/ TAPE 1.5%-10% KIT RX + OTC

COLCHICINE GLOPERBA COLCHICINE 0.6 MG/5 ML SOLUTION

NEW DOSAGE FORM

ANTINEOPLASTIC EGF RECEPTOR

BLOCKER MCCLON ANTIBODY

KANJINTI TRASTUZUMAB-ANNS 150 MG VIAL NEW STRENGTH

AGENTS TO TREAT MULTIPLE SCLEROSIS

VUMERITY DIROXIMEL FUMARATE 231 MG CAPSULE NEW ENTITY

SYMPATHOMIMETIC AGENTS BIORPHEN PHENYLEPHRINE

HCL 0.1 MG/ML AMPULE NEW STRENGTH

GLUCOCORTICOIDS DEXAMETHASONE

SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSP/PF 10 MG/ML SYRINGE NEW DOSAGE

FORM

ANTINEOPLASTIC EGF RECEPTOR

BLOCKER MCLON ANTIBODY

OGIVRI TRASTUZUMAB-DKST

420 MG VIAL, 150 MG VIAL

BIOSIMILAR FOR HERCEPTIN

JAUNS KINASE (JAK) INHIBITORS OLUMIANT BARICITINIB 1 MG TABLET NEW STRENGTH

LEUKOCYTE (WBC) STIMULANTS ZIEXTENZO PEGFILGRASTIM-

BMEZ 6 MG/0.6 ML

SYRINGE BIOSIMILAR TO

NEULASTA


DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

ERYTHROID MATURATION

AGENTS REBLOZYL LUSPATERCEPT-

AAMT 25 MG, 75 MG VIAL NEW ENTITY

ANTITUBERCULAR ANTIBIOTICS PRETOMANID PRETOMANID 200 MG TABLET NEW ENTITY

ANTI-CD20 (B LYMPHOCYTE) MONOCLONAL

ANTIBODY

TRUXIMA RITUXIMAB-ABBS 10 MG/ML VIAL BIOSIMILAR TO RITUXAN


NEW INDICATIONS (EXISTING DRUGS)

FARXIGA® October 21, 2019 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved FARXIGA (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Source: AstraZeneca NPLATE® October 18, 2019 Amgen today announced that the U.S. Food and Drug Administration (FDA) approved Amgen’s Supplemental Biologics License Application (sBLA) for Nplate ® (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia (ITP), a rare, serious autoimmune disease characterized by low platelet counts. The updated indication expands treatment with Nplate to newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. In December of last year, the FDA approved another sBLA for Nplate in the treatment of pediatric patients with ITP. Source: Amgen


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market [Posted 10/23/2019] Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries, together referred to as “Dr. Reddy’s”) confirms it had initiated a voluntary nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA. This recall follows the USFDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of ranitidine. To date, Dr. Reddy’s has not received any reports of adverse events related to the recall of Dr. Reddy’s Ranitidine products. The recall includes all quantities in the US that are within expiry. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Ranitidine is available as an over-the-counter (OTC) and prescription drug. Over-the-counter (OTC) ranitidine tablets are used to relieve heartburn associated with acid indigestion and sour stomach. OTC Ranitidine Tablets are also used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. Prescription ranitidine capsules are prescribed for the short-term treatment of active duodenal ulcer; maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers; treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis); short-term treatment of active, benign gastric ulcer; maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers; treatment of GERD (Gastroesophageal reflux disease); treatment of endoscopically diagnosed erosive esophagitis; and for maintenance of healing of erosive esophagitis. Dr. Reddy’s Ranitidine products can be identified by NDC numbers on the product label. All Ranitidine products with expiration dated September 2019 to June 2021 are being recalled:

Description Strength Type Pack Size NDC Ranitidine Capsules 150 mg, 60 150 mg Rx 60 ct bottle 5511112960 Ranitidine Capsules 150 mg, 500 150 mg Rx 500 ct bottle 5511112905 Ranitidine Capsules 300 mg, 30 300 mg Rx 30 ct bottle 5511113030 Ranitidine Capsules 300 mg, 100 300 mg Rx 100 ct bottle 5511113001 Ranitidine Tablets, USP 150mg, 190 (2x95) Tray (Sam’s Club)

150 mg OTC 190 ct (2x95) tray

150062076 (UPC Code 078742089720)

Ranitidine Tablets, USP 150mg, 95 (Walgreens)

150 mg OTC 95 ct bottle 0363-0010-62

Ranitidine Tablets, USP 150mg, 220 CT Btl (Walmart)

150 mg OTC 220 ct bottle 49034-404-65

Ranitidine Tablets, USP 150mg 50ct Btl (Kroger)

150 mg OTC 50 ct bottle 30142-505-50



150 mg OTC 24 ct bottle 30142-505-34

Ranitidine Tablets, USP 150mg 65 ct Btl (Walgreens)

150 mg OTC 65 ct bottle 0363-0010-61

Ranitidine Tablets, USP 150 TAB 65ct BTL CP32 (Walmart)

150 mg OTC 65 ct bottle 49035-404-61

Ranitidine Tablets, USP 150mg 200ct Btl (Walgreens)

150 mg OTC 200 ct bottle 0363-0010-01

Ranitidine Tablets, USP 150mg Tabs Btl, 24 (Walgreens)

150 mg OTC 24 ct bottle 0363-0010-34

Ranitidine Tablets, USP 75 TAB 30ct Bottle NG (CVS)

75mg OTC 30 ct bottle 69842-871-30

Ranitidine Tablets, USP 75mg TAB 30ct Btl (Walgreens)

75 mg OTC 30 ct bottle 0363-0131-30

Ranitidine Tablets, USP 75mg TAB 80ct Btl (Walgreens)

75 mg OTC 80 ct bottle 0363-0131-80

Ranitidine Tablets, USP 75 mg Tab 80ct Bottle NG (CVS)

75 mg OTC 80 ct bottle 0363-0131-80

Ranitidine Tablets, USP 75 mg Tab 160ct Bottle NG (CVS)

75 mg OTC 160 ct bottle 69842-871-37


75 mc OTC 30 ct bottle 30142-131-30

Ranitidine Tablets, USP 150 TAB 24ct BTL (CDMA)

150 mg OTC 24 ct bottle 63868-480-24

Ranitidine Tablets, USP 150 Tablet 130ct Bottle NC (Walmart)

150 mg OTC 130 ct bottle 49035-404-13


150 mg OTC 50 ct bottle 63868-480-50

Ranitidine Tablets, USP 75 Tab 60ct Btl (Dr. Reddy’s)

75 mg OTC 60 ct bottle 55111-131-50


75 mg OTC 60 ct bottle 63868-482-60


75 mg OTC 30 ct bottle 63868-482-30

Ranitidine Tablets, USP 150mg Tablets 24ct BTL00 (Dr. Reddy’s)

150 mg OTC 24 ct bottle 55111-404-34

Ranitidine Tablets, USP 150 Tab 95ct Btl (HCA)

150 mg OTC 95 ct bottle 43598-808-62

Ranitidine Tablets, USP 150 Tab 220ct Btl (HCA)

150 mg OTC 220 ct bottle 43598-808-65

Ranitidine Tablets, USP Tab 150mg 40ct Bottle (Target)

150 mg OTC 40 ct bottle 11673-849-40

Ranitidine Tablets, USP 150 Tab 24ct Btl (Thirty Madison)

150 mg OTC 24 ct bottle 71713-203-02


Ranitidine Tablets, USP 150 Tab 95ct Btl (Thirty Madison)

150 mg OTC 95 ct bottle 71713-203-05

Ranitidine Tablets, USP 75mg (GeriCare)

75 mg OTC All counts 57896-715

Ranitidine Tablets, USP 150mg (GeriCare)

150 mg OTC All counts 57896-717

If consumers have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality concerns experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online, Regular Mail or Fax: Download Form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA) Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S. [Posted 10/23/2019] As a precautionary measure, Sanofi on Friday, October 18, initiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®. Zantac tablets are an oral, over-the-counter product to prevent and relieve heartburn associated with acid ingestion and sour stomach. On September 13, 2019, the U.S Food and Drug Administration issued a public statement alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. products, Sanofi has made the decision to conduct the voluntary recall as the investigation continues. Active ingredients used in Sanofi’s ranitidine products outside of the U.S. and Canada are sourced from different suppliers. Sanofi has also issued a voluntary recall in Canada. The company is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Sanofi will be notifying its distributors and customers via email and via the Sanofi web site, and will arrange for return of all recalled products. Wholesalers (direct customers) will be asked to immediately


stop distribution and return any stock to Sanofi, and contact the retail outlets in their group to do the same. Retailers will be asked to immediately stop dispensing Zantac tablets and return remaining stock to Sanofi by contacting INMAR at 877-275-0993 (option 1) or via fax at 336-499-8145 or email at [email protected]. Consumers are asked to speak to their physician or pharmacist about alternate heartburn relief options. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online; or • Regular Mail or RAX: Download and complete the form, or call 1-800-332-1088 to request a

reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178

Source: U.S. Food and Drug Administration (FDA) Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine [Posted 10/25/2019] Novitium Pharma LLC (Novitium) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. To date, Novitium has not received any reports of adverse events related to use of the product as part of this recall. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Ranitidine Hydrochloride Capsules are indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label.

Description Strength Type Pack Size NDC Ranitidine Capsules 150 mg 150 mg Rx 60 ct bottle 70954-001-20 Ranitidine Capsules 150 mg 150 mg Rx 500 ct bottle 70954-001-40 Ranitidine Capsules 300 mg 300 mg Rx 30 ct bottle 70954-002-10 Ranitidine Capsules 300 mg 300 mg Rx 100 ct bottle 70954-002-40

Source: U.S. Food and Drug Administration (FDA) Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product [Posted 10/23/2019]

https://urldefense.proofpoint.com/v2/url?u=https-3A__www.fda.gov_safety_medwatch-2Dfda-2Dsafety-2Dinformation-2Dand-2Dadverse-2Devent-2Dreporting-2Dprogram&d=DwMGaQ&c=oqfTdqEg-5RVWdADx2p0eQfTJbhADUkp_fnDvmO98t0&r=GFbeXaWecwX8A35k8Dsg8RV3Fdh64S4DR1X7MjzPBfY&m=ZFk4nNi_4vncYdT1RGFwrf-QzVcR-lstDxsOqFJ3x0w&s=vow3S7zyZqhGiRj1Uh7cj_jfO3xcXcRyDsBZCmK0eoM&e=

https://urldefense.proofpoint.com/v2/url?u=https-3A__www.accessdata.fda.gov_scripts_medwatch_index.cfm&d=DwMGaQ&c=oqfTdqEg-5RVWdADx2p0eQfTJbhADUkp_fnDvmO98t0&r=GFbeXaWecwX8A35k8Dsg8RV3Fdh64S4DR1X7MjzPBfY&m=ZFk4nNi_4vncYdT1RGFwrf-QzVcR-lstDxsOqFJ3x0w&s=PWOlDhT9ytNC9Jfn5NGW9uJQa0z7vvErQziuX5_J-FI&e=

https://urldefense.proofpoint.com/v2/url?u=https-3A__www.fda.gov_media_85598_download&d=DwMGaQ&c=oqfTdqEg-5RVWdADx2p0eQfTJbhADUkp_fnDvmO98t0&r=GFbeXaWecwX8A35k8Dsg8RV3Fdh64S4DR1X7MjzPBfY&m=ZFk4nNi_4vncYdT1RGFwrf-QzVcR-lstDxsOqFJ3x0w&s=mIZjy4b-JSTr8PzdBOT6Gl7ywUZ8H_iwtj3XCvTr60M&e=


As a precautionary measure, Perrigo Company plc announced today that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Ranitidine is an over-the-counter (OTC) and prescription product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. After regulatory bodies announced that ranitidine may potentially contain NDMA, Perrigo promptly began testing of its externally sourced ranitidine API (active pharmaceutical ingredient) and ranitidine-based products. On October 8, 2019, Perrigo halted shipments of the product based upon preliminary results. Based on the totality of data gathered to date, Perrigo has made the decision to conduct this voluntary recall. Perrigo has the highest commitment to consumer safety and will continue to communicate ongoing testing results with health authorities. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Perrigo is notifying our retail customers by phone, email or other communication with recall notification communications to arrange for the return of all recalled product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Source: U.S. Food and Drug Administration (FDA) Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA) [Posted 10/25/2019] Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL to the consumer level due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the FDA for Ranitidine Hydrochloride Syrup (Ranitidine Oral Solution, USP). Lannett was notified by FDA of the potential presence of NDMA on September 17, 2019 and immediately commenced testing of the Active Pharmaceutical Ingredient (API) and drug product. The analysis confirmed the presence of NDMA.





Risk Statement: NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables. The product is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis and is packaged in bottles of 16 fluid ounces (one pint) (NDC 54838-550-80). The affected Ranitidine Syrup lots include the following:

NDC Code Batch Expiration Date

NDC Code Batch Expiration Date

54838-550-80 1503A 10/2019 54838-550-80 1646A 02/2020 54838-550-80 1504A 10/2019 54838-550-80 1647A 02/2020 54838-550-80 1505A 10/2019 54838-550-80 1668A 03/2020 54838-550-80 1523A 10/2019 54838-550-80 1669A 03/2020 54838-550-80 1524A 10/2019 54838-550-80 1670A 03/2020 54838-550-80 1525A 11/2019 54838-550-80 1708A 03/2020 54838-550-80 1561A 12/2019 54838-550-80 1709A 04/2020 54838-550-80 1562A 12/2019 54838-550-80 1710A 04/2020 54838-550-80 1563A 12/2019 54838-550-80 1729A 04/2020 54838-550-80 1589A 12/2019 54838-550-80 1730A 04/2020 54838-550-80 1590A 12/2019 54838-550-80 1731A 04/2020 54838-550-80 1591A 12/2019 54838-550-80 1757A 05/2020 54838-550-80 1614A 01/2020 54838-550-80 1758A 05/2020 54838-550-80 1615A 01/2020 54838-550-80 1759A 05/2020 54838-550-80 1617A 01/2020 54838-550-80 1773A 06/2020 54838-550-80 1644A 02/2020 54838-550-80 1774A 06/2020 54838-550-80 1775A 06/2020 54838-550-80 1989A 12/2020 54838-550-80 1794A 06/2020 54838-550-80 1990A 12/2020 54838-550-80 1795A 06/2020 54838-550-80 1991A 12/2020 54838-550-80 1796A 06/2020 54838-550-80 1998A 01/2021 54838-550-80 1817A 06/2020 54838-550-80 1999A 01/2021 54838-550-80 1818A 07/2020 54838-550-80 2000A 01/2021 54838-550-80 1819A 07/2020 54838-550-80 2019A 01/2021 54838-550-80 1840A 08/2020 54838-550-80 2020A 01/2021 54838-550-80 1840B 08/2020 54838-550-80 2065A 03/2021 54838-550-80 1841A 08/2020 54838-550-80 2066A 03/2021 54838-550-80 1842A 08/2020 54838-550-80 2067A 03/2021 54838-550-80 1863A 08/2020 54838-550-80 2071A 03/2021 54838-550-80 1864A 09/2020 54838-550-80 2072A 03/2021 54838-550-80 1865A 09/2020 54838-550-80 2073A 03/2021 54838-550-80 1899A 10/2020 54838-550-80 2076A 03/2021 54838-550-80 1900A 10/2020 54838-550-80 2077A 03/2021


54838-550-80 1901A 10/2020 54838-550-80 2078A 03/2021 54838-550-80 1910A 10/2020 54838-550-80 2126A 05/2021 54838-550-80 1911A 10/2020 54838-550-80 2127A 05/2021 54838-550-80 1912A 10/2020 54838-550-80 2128A 05/2021 54838-550-80 1918A 10/2020 54838-550-80 2164A 06/2021 54838-550-80 1919A 10/2020 54838-550-80 2165A 06/2021 54838-550-80 1920A 10/2020 54838-550-80 2166A 06/2021 54838-550-80 1925A 10/2020 54838-550-80 2179A 06/2021 54838-550-80 1926A 10/2020 54838-550-80 2180A 07/2021 54838-550-80 1927A 10/2020 54838-550-80 2181A 07/2021 54838-550-80 1977A 12/2020 54838-550-80 2214A 08/2021 54838-550-80 1978A 12/2020 54838-550-80 2215A 08/2021 54838-550-80 1979A 12/2020 54838-550-80 2216A 08/2021

The product can be identified by NDC number and batch numbers provided above. Ranitidine Syrup was distributed nationwide to wholesalers/distributors. Lannett is notifying its distributors and customers via email and via the Lannett website, and is arranging for return of all recalled products. Wholesalers and distributors (direct customers of Lannett) that have Ranitidine which is being recalled should contact Lannett customer service for instructions with regard to returning any remaining stock to Lannett. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Source: U.S. Food and Drug Administration (FDA) Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance [Posted 10/26/2019] Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance. Clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out. To date, Mylan has not received any adverse events related to this batch. Alprazolam Tablets are indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia.





Alprazolam Tablets, USP C-IV 0.5 mg, are packaged in bottles of 500. This batch was distributed in the U.S. between July 2019 and August 2019. The recalled lot is as follows:

NDC Product Description and Strength Size Lot number

Expiry

0378-4003-05

Alprazolam Tablets, USP C-IV 0.5mg Bottles of 500

8082708 September 2020

Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

• Wholesaler: Immediately examine your inventory, quarantine and discontinue distribution of these lots. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to [email protected] within 10 business days. Stericycle will notify your retail level customers that received the affected batches.

• Retailer: Immediately examine your inventory, quarantine and discontinue distribution of these lots. Additionally, if you have further distributed the product, please identify the consumer and notify them immediately of this product recall. The consumer should be instructed to contact Stericycle at 1-888-843-0255 for the documentation packet to return the product.

• Consumer: Please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or [email protected], Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Source: U.S. Food and Drug Administration (FDA) ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer’s Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter [Posted 10/31/2019] ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.





Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. To date, ICU Medical, Inc. has not received reports of adverse events related to this recall. The Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The affected product lots, manufactured in the U.S. for ICU Medical by Hospira, a Pfizer company in late 2017 and early 2018, are listed below:

NDC Number

Product Description

Lot Number*

Expiration Date

Configuration Manufacture Date

Distribution Dates

0409-7953-03

Lactated Ringer’s Injection, USP

84-603-FW 01-Dec-2019

500 mL Flexible Container

December 2017

February 2018-June 2018

0409-7983-25

0.9% Sodium Chloride Injection, USP

95-101-C6 01-May-2020

250 mL VisIVTM Container

November 2018

December 2018-March 2019

ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products. Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase. Customers with questions regarding this recall can call ICU Medical at 1-844-6547780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Source: U.S. Food and Drug Administration (FDA)





Fagron Inc. Issues Voluntary Nationwide Recall of LETS GET KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products [Posted 11/01/2019] Fagron Inc. is voluntarily recalling all unexpired lots of LETS GET KIT Convenience Packs to the hospital pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GET KIT Convenience Packs. FDA analysis identified Bacillus fortis/Geobacillus toebii, Bacillus spp, and Bacillus circulans as contaminants in some samples obtained during an inspection of Fagron Inc. This non-sterile product has the potential to result in an increased chance of infection at the site of administration during open wound care. The use of this or other non-sterile products in wound treatment may increase the risk of infection, especially for immunocompromised patients, the elderly or children. To date, Fagron Inc. has not received any reports of adverse events related to this recall. Fagron Inc. places the health and wellbeing of patients first and focuses on quality throughout our production processes. Fagron Inc. will contact all affected customers via a recall letter to arrange for the return of all products identified in the recall. The product is used as a topical anesthetic and is packaged in boxes containing lidocaine hydrochloride, epinephrine bitartrate, tetracaine hydrochloride, sodium metabisulfite, Suturagel Methylcellulose base, adapter cap and syringes. The affected LETS GEL KIT Convenience Pack lots include the following lot numbers and expiration dates.

Lot Number Expiration Date 18F25-U03-044296 11/8/2019 18F25-U04-044297 11/8/2019 18H22-U06-045284 1/24/2020 18I24-U05-045853 11/8/2019 18K06-U03-047041 1/24/2020 18K06-U04-047042 1/24/2020 18K27-U11-047460 3/16/2020 18K278-U10-047519 3/16/2020 19A06-U02-048182 3/16/2020 19A06-U03-048183 3/16/2020 19A16-U13-048363 3/16/2020 19A21-U02-048503 3/16/2020 19B10-U02-048787 3/16/2020 19B14-U05-048781 3/16/2020 19C05-U02-049199 3/16/2020 19C11-U07-049451 3/16/2020 19C25-U02-048758 3/16/2020 19D07-U01-049884 3/16/2020 19D07-U02-049885 3/16/2020 19E09-U01-050298 3/16/2020 19E23-U01-050763 9/11/2020 19F16-U12-000052 9/11/2020 19F16-U13-000053 10/24/2020


19G07-U01-000357 10/24/2020 19G07-U02-000358 10/24/2020 19G21-U01-000930 10/24/2020 19G21-U02-000931 12/17/2020 19H01-U01-001172 12/17/2020 19H01-U02-001174 12/17/2020 19I03-U01-002019 2/4/2021 19I03-U02-002020 2/4/2021 19I03-U03-002021 12/17/2020

This product can be identified by the product packaging and labeling. The product was distributed nationwide to hospitals, pharmacies and distributors. Fagron Inc. is notifying its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies and distributors that have LETS GETL KIT Convenience Packs which are being recalled should quarantine this material. Please immediately discontinue use or distribution of the affected lots. Consumers with questions regarding this recall can contact Stericycle via the following information. Phone: 877-448-5305 (8am – 5pm EST) FAX: 877-884-9410 Email: [email protected] Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related using the product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Source: U.S. Food and Drug Administration (FDA) Minimed Insulin Pumps by Medtronic: Class I Recall – Due to Potential Cybersecurity Risks [Posted 11/05/2019] BACKGROUND: People who have diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The pump includes a remote controller which is designed to communicate wirelessly with the pump to deliver a specific amount of insulin to the person with diabetes. ISSUE: Medtronic is recalling the specified insulin pumps due to potential cybersecurity risks. An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin

mailto:[email protected]





pump. This person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death. To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks. The affected products are the MiniMed Model 500 Remote control and 503 Remote Transmitter (MMT-500 and MMT-503). RECOMMENDATION: On June 27, 2019, Medtronic instructed patients to talk to their health care provider about a prescription to switch to a model with more cybersecurity protection. To minimize the potential risk of a cybersecurity attack while waiting for a replacement pump, Medtronic advised patients to:

• Keep their insulin pump and the devices that are connected to their pump within their control at all times whenever possible

• Do not share their pump serial number • Be attentive to their blood glucose levels closely and act appropriately • Immediately cancel any unintended boluses • Connect their Medtronic insulin pump to other Medtronic devices and software only • Disconnect the USB device from any computer when they are not using it to download data from

their pump Patients should seek medical help right away if they:

• Have symptoms of severe hypoglycemia (such as excessive sweating, feeling very tired, dizzy and weak, being pale, and a sudden feeling of hunger).

• Have symptoms of diabetic ketoacidosis (such as excessive thirst, frequent urination, nausea and vomiting, feeling very tired and weak, shortness of breath).

• Think their insulin pump settings or insulin delivery changed unexpectedly Health care providers and patients are encouraged to report adverse events or side effects related to the use of these products to FDA’s MedWatch Adverse Event Reporting program:








Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity [Posted 11/06/2019] Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150 mg to the retail level and 37 lots of Ranitidine Capsules 150 mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15 mg/mL to the consumer level due to the detection of NDMA Impurity in the finished product. The impurity detected is NDMA, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall. Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2 receptors found in gastric parietal cells. This results in decreased gastric acid secretion and gastric volume, and reduced hydrogen ion concentration. Uses are:

• Relieves heartburn associated with acid indigestion and sour stomach • Relieves heartburn associated with acid indigestion and sour stomach brought on by eating or

drinking certain foods and beverages Patients who prescribed or are taking Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL should continue taking their medicine. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. The products subject to recall are listed below and are packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Product Name NDC Batch Number Exp. Date Ranitidine Tablets 150mg 55910-092-79 NBSB19001DA3 Feb-2021 Ranitidine Capsules 150mg

59651-144-60 RA1518001-A Jul-2020 RA1518002-A Jul-2020

59651-144-05 RA1518002-B Jul-2020

RA1518003-A Jul-2020 RA1518004-A

Aug-2020

RA1518005-A Aug-2020 59651-144-60 RA1518005-B Aug-2020

RA1518006-A Aug-2020 59651-144-05 RA1518007-A Sep- 2020

RA1518008-A Sep-2020 RA1518009-A Sep-2020 RA1518010-A Oct- 2020


RA1518011-A Nov-2020 RA1518012-A Nov-2020 RA1518013-A Nov-2020 RA1518014-A Nov-2020 RA1518015-A Nov-2020

59651-144-60 RA1519003-A May-2021 59651-144-05 RA1519003-B May- 2021

RA1519004-A May- 2021 Ranitidine Capsules 300mg 59651-145-30 RA3018001-A Jul-2020

RA3018002-A Jul-2020 RA3018003-A Jul-2020 RA3018004-A Aug-2020 RA3018005-A Aug-2020 RA3018006-A Aug-2020 RA3018007-A Sep-2020 RA3018008-A Sep-2020 RA3018009-A Sep-2020 RA3018010-A Oct-2020 RA3019001-A Jan-2021 RA3019002-A Jan12021 RA3019003-A May-2021

Ranitidine Syrup (Ranitidine Oral Solution, USP) 15mg/mL (75mg/5mL)

65862-431-74 UI1519001-A May-2021 UI1519002-A May-2021 UI1519003-A May-2021 UI1519004-A May-2021

Ranitidine Tablets 150 mg, Ranitidine Capsules 150 mg, Ranitidine Capsules 300 mg, and Ranitidine Syrup 15 mg/mL were distributed nationwide to Aurobindo Pharma USA, Inc. and AuroHealth wholesale and distributor customers 28 September 2018 through 19 September 2019. Qualanex, on behalf of Aurobindo Pharma USA, Inc. will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter. Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:

• 1-866-850-2876 Option 2 • [email protected]

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 or email [email protected] (live calls received 7:00 am – 4:00 pm M-F CST).




Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Source: U.S. Food and Drug Administration (FDA) American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of NDMA Impurity [Posted 11/08/2019] American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is NDMA. This recall is being initiated in response to the recall by the manufacturer (Lannett Company, Inc.), which included affected lots that were repackaged by American Health Packaging. NDMA is classified as a probable human carcinogen, a substance that could cause cancer, based on laboratory testing. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. No reports of injury or adverse events to date. Ranitidine is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis. Product was distributed Nationwide to Wholesalers for use in hospital settings. The product/lots included in the expanded recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Product Description AHP Lot No.

Expiration Date

AHP Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Case NDC#: 60687-260-23 (Individual Dose NDC: 60687-260-42)

183723 184278 187652

10/31/2020 10/31/2020 5/31/2021

AHP Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Case NDC#: 60687-260-69 (Individual Dose NDC: 60687-260-42)

177874 178413 183449 184445 186563

01/31/2020 02/29/2020 10/31/2020 12/31/2020 03/31/2021





American Health Packaging has notified its distributors by recall letter, sent November 1st, 2019, to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. American Health Packaging is arranging for return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact (877)-475-5864 to receive a return packet. Hours of operation are 9:00am – 5:00pm, EST Monday thru Friday. Any general questions regarding the return of this product please contact Inmar Pharmaceuticals Services at 800-967-5952 (option 1). Hours of operation are 9:00am – 5:00pm, EST, Monday thru Friday. Consumers with questions regarding the recall can contact Inmar Pharmaceuticals Services at 800-967-5952 (option 1). Hours of operation are 9:00am – 5:00pm, EST, Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



Source: U.S. Food and Drug Administration (FDA) Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150 mg and 300 mg and Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, Due to Possible Presence of NDMA Impurity [Posted 11/12/2019] Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below. Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential NDMA amounts above levels established by the FDA. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Amneal Pharmaceuticals, LLC. Has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP), manufactured by Amneal, are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved





for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) subject to the recall can be identified by NDC numbers stated on the product label: The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots: Product Strength Pack Size NDC Number Ranitidine Tablets, USP 150 mg 60 count 65162-253-06 Ranitidine Tablets, USP 150 mg 100 count 65162-253-10 Ranitidine Tablets, USP 150 mg 180 count 65162-253-18 Ranitidine Tablets, USP 150 mg 500 count 65162-253-50 Ranitidine Tablets, USP 150 mg 1000 count 65162-253-11 Ranitidine Tablets, USP 300 mg 30 count 65162-254-03 Ranitidine Tablets, USP 300 mg 100 count 65162-254-10 Ranitidine Tablets, USP 300 mg 250 count 65162-254-25 Ranitidine Tablets, USP 300 mg 1000 count 65162-254-11 Ranitidine Tablets, USP 150 mg 500 count 53746-250-05 Ranitidine Tablets, USP 150 mg 1000 count 53746-253-10 Ranitidine Syrup (Oral Solution), USP 15 mg/mL; 16 fl. Oz. 473 mL 65162-664-90 The affected Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) were distributed directly to Wholesalers, Distributors, Retailers and Repackagers. Amneal is notifying its direct customers vial mail (USP Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted products directly from Amneal can call Stericycle at 866-918-8768, Monday-Friday, 8:00 am – 5:00 pm, EST to arrange for product return. Consumers who have Ranitidine Tablets, USP and Ranitidine Syrup (Ranitidine Oral Solution, USP) which are being recalled should stop using the product and can call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm, EST for further information. Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00am – 6:00 pm, EST, or e-mail at [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.









STUDIES AND RECENT TOPICS

Antidepressant Doesn’t Ease Obsessive Behaviors of Autism October 29, 2019 The commonly used antidepressant Prozac doesn't appear to help reduce obsessive-compulsive behavior in children and teens with autism, new research suggests. Source: healthday.com Vaccine shows promise for preventing active TB disease October 29, 2019 An experimental vaccine proved 50% effective at preventing latent tuberculosis infection from turning into active disease in a three-year study of adults in Africa. Doctors were encouraged because protection declined only a little after two years, and even a partially effective vaccine would be a big help against TB. The lung disease kills more than a million people a year, mostly in poor countries, and about one-third of the world’s people harbor the bacteria that cause it. Source: apnews.com Babies at higher risk for ADHD, autism if pregnant moms took acetaminophen October 30, 2019 Babies born to women who used acetaminophen late in pregnancy may be at increased risk of ADHD and autism spectrum disorder, a new study suggests. After examining stored blood samples from babies’ umbilical cords, researchers determined that the risks of ADHD and autism were significantly increased in children whose blood had high levels of acetaminophen breakdown products, according to a report in JAMA Psychiatry. Source: reuters.com Novartis’ Zolgensma study halted by FDA amid safety questions October 30, 2019 U.S. regulators have halted a trial of Novartis’s Zolgensma treatment after an animal study raised safety concerns, the company said on Wednesday, in a setback for the drugmaker’s plan to expand its use to older patients. Source: reuters.com


An Ebola Cure Emerged from a war zone October 31, 2019 In a medical breakthrough, two new drugs are saving lives from the Ebola virus and helping uncover tools against other deadly infectious diseases. They were proven effective in a gold-standard clinical trial conducted by an international coalition of doctors and researchers in the middle of armed violence. The work of Congolese virologist Jean-Jacques Muyembe Tamfum, director-general of Congo's National Institute of Biomedical Research, known as the INRB, yielded one of the new Ebola drugs. He was among the first scientists to identify the Ebola virus, which has taken the lives of an estimated 3,000 people in his country and threatened many more around the world. Researchers tested four experimental drugs, and two were most effective. The trial was conducted at four Ebola treatment centers, essentially tent-sided field hospitals, scattered across a violent swath of northeastern Congo during the world's second-largest outbreak of the disease. In addition to the threat from the contagious virus, researchers dodged attacks by warring local groups. Two of the treatment centers were set on fire. Preliminary results were released on August 12, days after the trial ended. Final results are expected to be published soon in a medical journal. Beyond Ebola, the new drugs open a pathway for antibody-based treatments for other infectious diseases, said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, which ran the trial with the INRB and a research group coordinated by the World Health Organization. Source: pharmacist.com FDA downplays risks from already recalled heartburn Zantac November 1, 2019 The U.S. Food and Drug Administration on Friday downplayed the risk caused by contamination of the already recalled popular heartburn drug Zantac, and said its tests suggest it does not cause carcinogens to form after ingestion by patients. Source: reuters.com Novartis says delayed telling FDA of Zolgensma concern due to ‘mistake’ November 1, 2019 Novartis scientists learnt months ago about safety concerns surrounding its gene therapy Zolgensma but delayed telling the U.S. Food and Drug Administration (FDA) due to what the Swiss drugmaker said was a “mistake”. Source: reuters.com Counterfeit prescription pills made of fentanyl are killing Americans: DEA November 4, 2019 The Drug Enforcement Administration issued a warning on Monday about counterfeit prescription pills, saying the pills are "killing Americans."


"Mexican drug cartels are manufacturing mass quantities of counterfeit prescription pills containing fentanyl,” according to a press release from the DEA. Source: abcnew.go.com Opioids: The Pharmacist’s Role November 5, 2019 As the opioid crisis rages on (130 people die of opioid overdoses each day), pharmacists face a number of challenges: how do you keep potentially dangerous medications from those who abuse them while not making things overly difficult for the chronic pain patients who rely on them—all while maintaining a busy pharmacy? Source: drugtopics.com Long-Acting Birth Control in a Patch? November 7, 2019 Researchers have developed a skin patch that might one day give women the ability to self-administer long-acting birth control. The patch, which contains “micro-needles” absorbed into the skin, is seen as a possible alternative to current long-acting contraceptives. Those methods- intrauterine devices (IUDs) and contraceptive implants- are highly effective at preventing pregnancy. But they have to be inserted by a health care professional, which can be a barrier. Source: healthday.com Dupilumab Has Consistent Effect on Asthma Control Across Different IgE Levels November 9, 2019 Dupilumab has demonstrated consistency in effective asthma control across baseline levels of immunoglobulin E (IgE) among individuals with uncontrolled, moderate to severe asthma with high baseline eosinophils. This research was presented at the 2019 American College of Asthma, & Immunology Annual Scientific Meeting, held November 7 to 11, 2019, in Houston, Texas. Source: pulmonologyadvisor.com Common Muscle Relaxant Could Pose Mental Dangers for Seniors November 9, 2019 A commonly prescribed muscle relaxant known as baclofen can leave older kidney patients so disoriented that they land in the hospital, a new study warns. Source: healthday.com


Concurrent Methotrexate and Pegloticase as a Treatment for Uncontrolled Gout November 12, 2019 Pegloticase (Krystexxa) in combination with methotrexate could be an effective treatment for uncontrolled gout, according to the results of a recent study presented at the 2019 American College of Rheumatology annual meeting in Atlanta, GA. Source: mdmag.com Aspirin May Decrease Growth of Intracranial Aneurysms November 12, 2019 Aspirin may reduce the rate of aneurysm growth for patients with multiple intracranial aneurysms, according to a retrospective review published online October 29 in the Journal of Neurosurgery. Source: journals.lww.com


RECALLS

Product Type Product Description Classification Code Info Reason for Recall Recalling

Firm Drugs Mero Macho Artificially

Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028

Class I

Lot #: ZD-078-19 Exp. 27-04-2020

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

FITOTERAPIA USA, INC

Drugs

Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.

Class I

Lot #: XC12, EXP 12/2020; XC06, EXP06/2021; XC10, EXP 10/2021; XC02, EXP 02/2022; XC04, EXP 04/2022; XC06, EXP06/2022

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

GL Holdings

Drugs

LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03

Class I

Lot: 84-603-FW Exp. 01 DEC 2019

Presence of Particulate Matter.

ICU Medical Inc

Drugs

0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25

Class I

Lot: 95-101-C6 Exp. 01 MAY 2020

Presence of Particulate Matter.

ICU Medical Inc

Drugs del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10

Class II

Lots: NC9048A Exp. 10/14/2019; NC9048B Exp. 10/14/2019; NC9049A Exp. 10/16/2019; NC9049B Exp.

Lack of Assurance of Sterility; bags have potential to leak

Nephron Pharmaceuticals Corporation dba Nephron Sterile



Firm

10/16/2019; NC9051A Exp. 10/21/2019; NC9051B Exp. 10/21/2019; NC9052A Exp. 10/22/2019; NC9052B Exp. 10/22/2019; NC9053A Exp. 10/23/2019; NC9053B Exp. 10/23/2019; NC9054A Exp. 10/28/2019; NC9054B Exp. 10/28/2019; NC9055A Exp. 10/30/2019; NC9056B Exp. 11/04/2019

Compounding Center

Drugs PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25

Class II

Lots: FB9001 A Exp. 10/31/2019, FB9001B Exp. 10/31/2019; FB9013A Exp. 12/08/2019; FB9015A Exp. 12/14/2019

GMP Deviations: potential glass contamination

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Drugs PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25

Class II

Lots: FB9014A Exp. 12/09/2019; FB9017A Exp. 12/16/2019



Drugs PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride

Class II

Lot: FR9002A Exp. 12/12/2019


Nephron Pharmaceuticals



Firm Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20

Corporation dba Nephron Sterile Compounding Center

Drugs Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8

Class II

Lot #: K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Taro Pharmaceuticals U.S.A., Inc.

Drugs Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9

Class II

Lot #: J78402968, J784129698, Exp 9/19; K765129698, K765229698, K765329698, K769329698, K778829698, K778929698, Exp 10/19; A887230568, A887330568, A887430568, Exp 12/19; B865430568, B865530568, B865630568, B869530568, B869630568, Exp 1/20; D866431198, D866531198, D866631198, D866731198, D866831198,





Firm D866931198, D872631198, D872731198, D872831198, D872931198, D873031834, Exp 3/20; E875331834, E875431834, E883831834, E883931834, E884031834, E884131834, Exp 4/20; F865131834, Exp 5/20; G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, G882232436, Exp 6/20; H865232436, H865332436, H870832436, Exp 7/20; I885233156, I885333156, I885433156, I885533156, I885633156, I885733164, Exp 8/20; J868533164, J868633164, J868733164, J868833164, J868933164 and J869033164, Exp 9/20; L866434042,



Firm L866534043, L866634044, L866734045, L866834046, L866934422, Exp 11/20; A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, A979834428, Exp 12/20; B974034749, B974134750, B974234751, B974334752, B974434753, Exp 1/21

Drugs Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8

Class II

Lot #: E875131667, E875231667, Exp 4/20; J871033189, J871133189, Exp 9/20; A972934375, A973034375, Exp 12/20



Drugs Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1

Class II

Lot #: J871033187, Exp 9/20





Firm Drugs Children's Ibuprofen Oral

Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04

Class II

Lot #: A972834374, Exp 12/20



Drugs Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Class II

Lot #: INX 530 Exp. 11/6/19; INX 535 Exp. 11/15/19; INX 540 Exp. 2/1/20; INX 545 Exp. 2/15/20; INX 550 Exp. 3/9/20; INX 555 Exp. 3/26/20; INX 560 Exp. 5/3/20; INX 565 Exp. 5/18/20; INX 570 Exp. 6/28/20; INX 575 Exp. 7/18/20

Lack of Sterility Assurance.

Innoveix Pharmaceuticals Inc

Drugs Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Class II

Lot #: INX 910 Exp. 2/7/20; INX 915 Exp. 3/12/20



Drugs Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Class II

Lots: SER 925 Exp. 11/4/19; SER 930 Exp. 11/18/19; SER 935 Exp. 2/21/20; SER 400 Exp. 4/1/20; SER 405 Exp. 5/11/20; SER 410 Exp. 7/15/20



Drugs Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only,

Class II

Lots: INX 50 Exp. 5/1/20





Firm Compounded by: Innoveix Addison, TX 75001 800-370-1910

Drugs Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

Class II

Lot #: 3089793, Exp. Date September 2020

Failed Dissolution Specification: Low out of specification dissolution results.

Mylan Pharmaceuticals Inc.

Drugs Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.

Class II

Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Glenmark Pharmaceuticals Inc., USA

Drugs AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Class II

Lot 17708 Exp.11/30/2019 Lot 18459 Exp.03/31/2020 Lot 19033 Exp.07/31/2020 Lot 19032 Exp.07/31/2020 Lot 19031 Exp.06/30/2020 Lot 20204 Exp.09/30/2020 Lot 20205 Exp.09/30/2020 Lot 20663 Exp.10/31/2020 Lot 20664 Exp.11/30/2020 Lot 20665 Exp.11/30/2020

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Inc.



Firm Lot 20666 Exp.11/30/2020 Lot 21039 Exp.12/31/2020 Lot 21920 Exp.04/30/2021

Drugs AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Class II

Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Inc.

Drugs

S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

Class II

Lot #: S06272019DT@08, BUD: 9/27/2019

Lack of Assurance of Sterility

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Drugs

S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.

Class II

Lot #: a) S04112019DT@07,Exp 8/11/19; S05012019DT@01, 9/1/19; S05142019DT@13, 9/14/19; S05282019DT@07, 9/28/19; S06042019DT@05, 10/4/19; S06182019DH@15, 10/18/19; S07102019DT@13, 12/10/19; S07172019DT@09, 12/17/19





Firm b) S04172019DT@01, 8/17/19; c) S07172019DT@09, 12/17/19

Drugs

S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX

Class II

Lot #: S07222019DH@09, Exp 8/22/19


Drugs

S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.

Class II

Lot #: a) S06112019DH@22, Exp 9/11/19; S06202019DT@10, Exp 9/20/19; S07312019DH@07, Exp 10/31/19; b) S07302019DH@07, Exp 10/30/19



Drugs

S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX

Class II

Lot #: S05232019DH@03, Exp 8/23/19; S07172019DT@03,Exp 10/17/19;



Drugs

S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.

Class II

Lot #: S05232019DH@04, Exp 8/23/19



Drugs

S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding RX.

Class II

Lot #: S05132019DH@02, Exp 8/13/19; S05142019DT@0


First Royal Care Co. LLC, dba Red



Firm 5, Exp 8/14/19;

S07032019DT@10, Exp 10/3/19; S07182019DH@01, Exp 10/18/19

Mountain Compounding Pharmacy

Drugs

S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.

Class II

Lot #: S03142019DT@09, Exp 9/14/19; S05052019DH@04, Exp 11/5/19; S06192019DT@03, Exp 12/19/19; S06262019DT@12, Exp 12/26/19



Drugs

S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX

Class II

Lot #: S07092019DT@14, Exp 8/9/19



Drugs

S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX

Class II

Lot #: a) 03072019DH@08, Exp 9/7/19; S04042019DT@04, Exp 10/4/19; S05012019DH@04, Exp 11/1/19; S05242019DT@12, Exp 11/24/19; S06182019DH@12 Exp 12/18/19; S06182019DH@32, Exp 12/18/19; S07152019DH@02, Exp 1/15/20; b) S06202019DT@05, Exp 12/20/19;



Drugs

S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV,

Class II

Lot #: S07312019DH@15, Exp 8/31/19





Firm 10 ml glass vial, Red Mountain Compounding Rx


Drugs

S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.

Class II

Lot #: a) S05312019DT@03, Exp 8/31/19;S06032019DT@05, Exp 9/3/19 S06122019DT@07, Exp 9/12/19; b) S05312019DT@07, Exp 8/31/19; S06122019DT@07, Exp 9/12/19;S06252019DH@11, Exp 9/25/19; S07172019DT@01, Exp 10/25/19



Drugs

S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx

Class II

Lot #: S07292019DH@13, Exp 8/29/19



Drugs

S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX

Class II

Lot #: S03072019DH@08; Exp 9/7/19; S02142019DH@08, Exp 8/14/19; S03072019DH@07, Exp 9/7/19; 03072019DH@08, 9/7/19; S03042019DH@07, Exp 9/4/19, S04172019DT@02, Exp 10/17/19; S05232019DT@1





Firm 0, Exp 11/23/19; S06242019DH@10, Exp 12/24/19; S07172019DT@07, Exp 1/17/20; S07242019DH@09, Exp 1/24/20

Drugs

S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX

Class II

Lot #: S06092019DH@09, Exp 9/9/19; S06252019DT@11, 9/25/19; S07092019DT@07, Exp 10/9/19; S07092019DT@13, Exp 10/9/19;



Drugs

S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.

Class II

Lot #: S05092019DH@06, Exp 8/9/19



Drugs

S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx

Class II

Lot #:a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19;





Firm Drugs

S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.

Class II

Lot #: S06262019DT@08, Exp 9/26/19;



Drugs

S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.

Class II

Lot #: S05212019DT@06 Exp, 5/21/19; S06262019DT@08, Exp 6/26/19



Drugs

S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.

Class II

Lot #: a) S04232019DT@07, Exp 8/23/19; S07302019DH@09, Exp 11/30/19, b) S05142019DT@14, Exp 9/14/19; S06182019DH@30, Exp 10/18/19; S06182019DH@13, Exp 10/18/19;


Drugs

S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX

Class II

Lot #: S05092019DH@08, Exp 8/9/19; S06112019DH@14, Exp 9/11/19; S07222019DH@04, Exp 10/22/19;



Drugs

S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.

Class II

Lot #: S07232019DH@10, Exp 10/23/19; S08012019DH@03, Exp 11/1/19;





Firm Drugs

S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.

Class II

Lot #: S06162019DH@09, Exp 9/16/19; S06032019DT@01, Exp 9/30/19;



Drugs

S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.

Class II

Lot #: S07292019DH@08, Exp 9/29/19



Drugs

S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding Pharmacy

Class II

Lot #: S07092019DT@18, Exp 8/23/19; S07312019DH@08, Exp 10/14/19



Drugs

S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX

Class II

Lot #: S07262019DH@02, Exp 8/26/19



Drugs

S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX

Class II

Lot #: a) S06252019DH@12, Exp 9/25/19; S07162019DT@02, Exp 10/16/19; b) S05162019DH@19, Exp 8/16/19; S05072019DT@08, Exp 8/7/19; S05082019DT@07, Exp 8/8/19;





Firm S05282019DT@08, Exp 8/28/19; S05312019DT@05, Exp 8/31/19; S06182019DH@11, Exp 9/18/19; S06242019DH@09, Exp 9/24/19; S07102019DT@06, Exp 10/10/19; S07162019DT@03, Exp 10/16/19; S07222019DH@10, Exp 10/22/19;

Drugs

S-GLYCERIN 72% INJECTION SOLN, 30ML glass vial, Red Mountain Compounding RX

Class II

Lot #: S05142019DT@09, Exp 8/14/19; S07162019DT@14, Exp 10/16/19; S07232019DH@06, Exp 10/23/19



Drugs

S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX

Class II

Lot #:a) S07292019DH@01, Exp 9/29/19;S07232019DH@06, Exp 9/23/19;S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/11/19; S06112019DH@11, Exp 8/11/19;S06142019DH@02, Exp 8/14/19; S06162019DH@01, 8/16/19,S06182019DH@34, Exp 8/18/19; S06242019DH@16, Exp 8/24/19;





Firm S06302019DH@05, Exp 8/30/19, S07102019DT@16, Exp 9/10/19; S07162019DH@02, Exp; 9/16/19, S07262019DH@03, Exp 9/26/19; S08022019DH@02, Exp 10/2/19; S07232019DH@06, Exp 9/23/19, c) S07102019DT@07, Exp 9/10/19;

Drugs

S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX

Class II

Lot #: S07232019DH@13, Exp 8/23/19; S07312019DH@14, Exp 8/31/19



Drugs

S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compounding RX

Class II




Drugs

S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX

Class II




Drugs

S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx.

Class II

Lot #:S07242019DH@05, Exp 10/24/19


First Royal Care Co. LLC, dba Red Mountain



Firm Compounding Pharmacy

Drugs

S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain Compounding Rx

Class II

Lot #: S06192019DT@09, Exp 9/19/19;



Drugs

S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx

Class II

Lot #: S05162019DH@10, Exp 8/16/19



Drugs

S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx

Class II

Lot #: S06242019DH@04, Exp 9/24/19



Drugs

S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx

Class II

Lot #: S06112019DH@16, Exp 9/11/19; S06182019DT@02, Exp 9/18/19; S06182019DH@33, Exp 9/18/19; S06252019DT@08, Exp 9/25/19; S08022019DH@01, Exp 11/2/19;



Drugs

S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx

Class II

Lot #: S06192019DT@02, Exp 8/19/19; S06262019DT@11, Exp 8/26/19;


First Royal Care Co. LLC, dba Red Mountain Compoundi



Firm S07312019DH@06, Exp 9/31/19

ng Pharmacy

Drugs

S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx

Class II

Lot #: S07292019DH@06, Exp 8/12/19



Drugs

S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx

Class II

Lot #: S07162019DH@15, Exp 8/16/19



Drugs

S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx

Class II

Lot #: S06192019DT@04, Exp 9/19/19



Drugs

S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx

Class II




Drugs

S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX

Class II

Lot #: a) S05162019DH@10, EXP 08/16/2019,S05242019DT@07, EXP 8/24/19, S07182019DT@14 EXP 10/18/19, b)





Firm S05162019DH@18, Exp 8/16/19;S07102019DT@04, EXP 10/10/19,S07262019DH@10 EXP 10/26/19, S07292019DH@10 EXP 10/29/19

Drugs

S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, Rx Only, Red Mountain Compounding RX.

Class II

Lot #: S02142019DH@01, Exp 8/14/19; S03112019DT@04, Exp 09/11/2019, S03192019DT@04, Exp 9/19/19; S04162019DT@15, Exp 10/16/19; S07172019DT@10, Exp 1/17/20; S07232019DH@04, Exp 1/23/20;



Drugs

S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.

Class II

Lot #: S07022019DT@02, Exp 10/2/19



Drugs

S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.

Class II

Lot #: S06242019DH@08, Exp 9/24/19; S07242019DH@08, Exp 10/24/19; S07312019DH@03, Exp 10/31/19



Drugs

S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.

Class II

Lot #: S07092019DT@08, Exp 8/9/19





Firm Compounding Pharmacy

Drugs

S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.

Class II

Lot #: S0726209DH@07, Exp 10/26/19



Drugs

S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx.

Class II

Lot #: S05232019DT@13, Exp 8/23/19



Drugs

S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.

Class II

Lot #: S03072019DH@10, Exp 9/7/19; S04162019DT@18, Exp 10/16/19; S05162019DH@09, Exp 11/16/19; S05232019DT@11, Exp 11/23/19; s06182019dh@31, Exp 12/18/19; S06242019DH@14, Exp 12/24/19; S07172019DT@08, Exp 1/17/20; S07232019DH@16, Exp 1/23/20; S06242019DH@14, Exp 12/24/19



Drugs

S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mountain Compounding Rx.

Class II

Lot #: S06302019DH@03, Exp 8/30/19





Firm ng Pharmacy

Drugs

S-SOD CITRATE 4% INJ SOLN MDV, 10 ML glass vial, Red Mountain Compounding Rx

Class II

Lot #: S07102019DT@12, Exp 8/10/19



Drugs

S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx

Class II

Lot #: S03062019JL@11, Exp 9/6/19; S04282019DH@05, Exp 10/28/19; S06182019DT@04, Exp 12/18/19; S06242019DH@11, Exp 12/24/19; S07232019DH@15, Exp 1/23/20



Drugs

S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx

Class II




Drugs

S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx

Class II

Lot #:a) S02132019DT@02, Exp 8/13/19; b) S04092019DT@05, Exp 10/9/19; S06122019DH@35, Exp 12/12/19; S06172019DH@04, Exp 12/17/19;



Drugs

S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP 12.5MG/NANDROLONE DECA 12.5), Rx Only, 5ML glass

Class II

Lot #: S05302019DT@03Exp 08/30/2019,





Firm vial. Red Mountain Compounding Rx.

Compounding Pharmacy

Drugs

S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.

Class II

Lot #: S06142019DH@01, Exp 8/14/19;



Drugs

S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx

Class II

Lot #: S07232019DH@08 Exp 10/23/19



Drugs

S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mountain Compounding Rx.

Class II

Lot #: S07292019DH@16, Exp 10/29/19



Drugs

S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.

Class II

Lot #: S04092019DT@16, Exp 8/9/19; S05012019DT@08, Exp 9/1/19; S05152019DT@01, Exp 9/15/19; S06112019DH@18, Exp 10/11/19; S06122019DT@06, Exp 10/12/19; S06192019DT@10, Exp 10/19/19; s07092019dt@16, Exp 11/9/19; S07242019DH@10, Exp 11/24/19





Firm Drugs

S-ZINC SULFATE 1MG/ML MDV SOLN, Rx only, 10mL glass vial. Red Mountain Compounding Rx.

Class II

Lot # S06112019DH@13, Exp 9/11/19; S06162019DH@03, Exp 9/16/19; S06182019DH@08, Exp 9/18/19; S06242019DH@12, Exp 9/24/19; S07162019DT@10, Exp 10/16/19



Drugs

S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX

Class II

Lot #: S07162019DT@05 exp: 8/14/2019



Drugs

S-DMSO 6.25% OPTH SOLN, 10 ml dropper bottle, Rx Only, Red Mountain Compounding Rx

Class II

Lot #:S05082019ST@05, Exp 8/8/19; S05212019DT@08, Exp 8/21/19; S05312019DT@10, Exp 8/31/19; S06272019DT@03, Exp 9/27/19; S07222019DH@06, Exp 10/22/19



Drugs

S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.

Class II

Lot #:S07232019DH@14 Exp 8/23/19; S07162019DT@06 Exp 8/16/19; S07172019DT@04 Exp 8/17/19



Drugs

S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.

Class II

Lot #:S05092019DH@07, Exp 8/9/19; S05082019DT@11, Exp 8/8/19; S07032019DT@1





Firm 3, Exp 10/3/19; S07092019DT@09, Exp 10/9/19; S07292019DH@03, Exp 10/29/19

ng Pharmacy

Drugs

S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.

Class II

Lot# S06062019DH@03, Exp 9/6/19; S06182019DH@01, Exp 9/18/19



Drugs

S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, Red Mountain Compounding Rx.

Class II

Lot# S05162019DH@17, Exp 8/26/19; S07262019DH@08, Exp 10/26/19



Drugs

S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.

Class II

Lot #: S06272019DT@07, Exp 8/27/19; S07262019DH@04, Exp 9/26/19; S07302019DH@04, Exp 9/30/19;



Drugs

S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.

Class II

Lot #: a) S06112019DH@10, Exp 8/11/19; b) S06112019DH@10, Exp 8/11/19, S06142019DH@03, Exp 8/14/19, S06252019DH@14, Exp 8/25/19, S07222019DH@02, Exp 9/22/19,



Drugs

S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass

Class II

Lot#: S05232019DT@01, Exp 8/23/19;


First Royal Care Co. LLC, dba



Firm vial, Red Mountain Compounding Rx

Red Mountain Compounding Pharmacy

Drugs

S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mountain Compounding Rx

Class II

Lot #:a) S07162019DT@04, Exp 10/16/19; b) S07162019DT@04 Exp 10/16/19



Drugs

S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red Mountain Compounding Rx

Class II

Lot #:a) S06242019DH@07; 9/24/19 b) S07222019DH@09, Exp 10/22/19; S05292019DT@06, Exp 8/29/19; S06032019DT@08, Exp 9/3/19; S06242019DH@07; 9/24/19



Drugs

S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx,

Class II

Lot #:S07092019DT@20, Exp 10/9/19; S07242019DH@08, Exp 10/24/19



Drugs

S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx

Class II

Lot #: S05162019DH@12, Exp 8/16/19; S05282019DT@06, Exp 8/28/19; S05302019DT@05, Exp 8/30/19; S06182019DT@03, Exp 9/18/19; S07102019dt@05, Exp 10/10/19; S07162019DT@0





Firm 8, Exp 10/16/19; S07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/19; S06242019DH@01, Exp 9/24/19; S07032019DT@10, EXP 10/03/2019, S07102019DT@05, Exp 10/10/2019, 07242019DH@02, Exp 10/24/19; S07252019DH@08, Exp 10/25/2019, S07292019DH@15, Exp 10/29/19;

Drugs

S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RX

Class II

Lot #:S05082019DT@16, Exp 8/8/19, S06052019DT@07, Exp 9/5/19;



Drugs

S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain Compounding RX

Class II

Lot #: S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19



Drugs

S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Red Mountain Compounding RX.

Class II

Lot #: S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19





Firm Drugs

S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.

Class II

Lot #: a) S03272019DT@04, Exp 09/27/2019, b) S01302019DT@08, Exp 08/30/2019, S02192019DH@10, Exp 08/19/2019, S03072019DH@01, Exp 09/07/2019, S03042019DH@02, Exp 09/07/2019, S03272019DT@04, Exp 09/27/2019, S04172019DT@03, Exp 10/17/2019, S04302019DT@11, Exp 10/30/2019, S05162019DH@20, Exp 11/16/2019, S05292019DT@03, Exp 11/29/2019, S06252019DH@17, Exp 12/25/2019, S07172019DT@12, Exp 01/17/2020, S07182019DT@08, Exp 01/18/2020,



Drugs

S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding Rx.

Class II

Lot #: S03302019DT@02, Exp 09/30/2019,





Firm S05062019DH@1

2, Exp 11/06/2019, S06162019DH@13, Exp 12/16/2019, S07132019DT@05, Exp 01/13/2020,


Drugs

S-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Mountain Compounding Rx.

Class II

Lot #: S05242019DT@10, Exp 08/31/2019,



Drugs

S-MICB12C/Carnitine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding Rx.

Class II

Lot #: S07092019DT@19, Exp 08/09/2019, S07292019DH@09, Exp 08/29/2019,



Drugs

S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx

Class II

Lot #:a) S04162019DH@04, Exp 8/16/19;S04182019DT@11, Exp 8/18/19; S04302019DT@08, Exp 8/30/19; S05292019DT@11, Exp 9/29/19; S06092019DH@08, Exp 10/9/19, S06252019DH@15, Exp 10/25/19; S07022019DH@10, Exp 11/2/19, S07292019DH@11, Exp 11/29/19; b)





Firm S06032019DT@02, Exp 10/3/19; S07232019DH@03, Exp 11/23/19

Drugs

S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx.

Class II

Lot #: S05292019dt@01, Exp 8/29/19;



Drugs

S-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mountain Compounding Rx.

Class II

Lot #: S03152019JL@03, Exp 9/15/19;



Drugs

S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a) 5 mL b) 10 mL c) 13 mL glass vial, Red Mountain Compounding Rx.

Class II

Lot #: S02192019DH@14, Exp 8/19/19; S02282019DH@06, Exp 8/28/19; S03142019DT@04, Exp 9/14/19; S03252019DH@03, Exp 9/25/19; S04102019DT@05, Exp 10/10/19; S05012019DT@03, Exp 11/1/19; S05022019DT@11, Exp 11/2/19; s05012019dt@09, Exp 11/2/19; S5212019DH@14, Exp 11/21/19; S06032019DT@07, Exp 12/3/19; S06122019DT@08, Exp 12/12/19; S07162019DT@1





Firm 3, Exp 1/16/20; S07262019DH@05, Exp 1/26/20; S05212019DH@14, Exp 8/21/19;

Drugs

S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx

Class II

Lot #: S07162019DT@12, Exp 1/16/20;



Drugs

S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx

Class II

Lot #: S06162019DH@02, Exp 9/16/19;



Drugs

S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.

Class II

Lot #: S02072019DT@08, EXP 9/7/19; S02132019DH@06, Exp 8/13/19; S02232019DH@06 Exp 8/23/19; S02282019DH@07 Exp 8/28/19; S02252019DH@01 Exp 8/25/19; S02122019DH@06 Exp 8/12/19; S03132019DT@02 Exp 9/13/19;03202019DT@01 Exp 9/20/19; S03282019DT@05 Exp 9/28/19 S03212019DT@01 Exp 9/21/19 S04202019DT@0





Firm 3 Exp 10/20/19 S0412019DT@03 Exp 10/10/19 S04102019DT@12 Exp 10/10/19 S04232019DT@02 Exp 10/23/19 S03132019DT@03 Exp 9/13/19 S04232019DT@05 Exp 10/23/19 S05072019DT@07 Exp 11/7/19 S05242019DT@04 Exp 11/24/19 S06032019DT@06 Exp 12/3/19 S06182019DH@23 Exp 12/18/19 S06182019DH@22 Exp 12/18/19; S06252019DH@15, Exp 12/25/19 S06182019DH@24 Exp 12/18/19 S06262019DH@15 Exp 12/26/19 S07032019DT@03 Exp 1/3/20 S07132019DH@02 Exp 1/13/20 S07232019DH@11 Exp /23/20 S07182019DT@09 Exp 1/18/20 S07292019DH@02 Exp 1/29/20 S07312019DH@10 Exp 1/31/20 S05072019DT@07 Exp, 9/30/19 S06182019DH@23 Exp,11/30/19



Firm Drugs

S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx

Class II

Lot #: S02252019DH@07, Exp 8/25/19; S03202019DT@02, EXP, 8/25/19; S03212019DT@02, EXP, 9/21/19; S04232019DT@06, EXP, 10/23/19; S05232019DT@06, EXP, 11/23/19; S05152019DH@12, EXP, 11/15/19; S05242019DT@03, EXP, 11/24/19; 05152019DH@12, EXP, 11/15/19; S06262019DT@02, EXP, 12/26/19; S07032019DT@12, EXP, 1/3/20; S07132019DT@03, EXP, 1/13/20; S07162019DT@01, EXP, 1/16/20; S07262019DH@06, EXP, 1/26/20; S05152019DH@12, EXP, 11/15/19;



Drugs

S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx

Class II

Lot #: S07162019DH@08, Exp 10/16/19; S05092019DH@05, Exp 8/9/19;



Drugs

S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.

Class II

Lot #: a) S05212019DH@13, Exp 8/21/19; S06302019DH@07, Exp 9/30/19; S07252019DH@10, Exp 10/25/19;





Firm b) S05092019DH@05, Exp 8/9/19;

ng Pharmacy

Drugs

S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.

Class II

Lot #: S06242019DH@06, Exp 9/24/2019;



Drugs

S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.

Class II

Lot #:a) S06182019DH@03, Exp 9/18/19; S07292019DH@04, Exp 10/29/19; b) S07092019DT@12, Exp 10/9/19;



Drugs

S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.

Class II

Lot #:S04222019DH@03 Exp 10/22/2019, S06162019DH@05, Exp 12/16/2019



Drugs

S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.

Class II

Lot #:S07132019DT@01, Exp 10/13/19;S07312019DH@05, Exp 10/31/19 S06122019DT@09, Exp 9/12/19;



Drugs

S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx

Class II

Lot #:S04102019DT@09, Exp 8/10/19; S05012019DT@03, Exp 9/1/19; S05162019DH@21, Exp 9/16/19; S05152019DH@2





Firm 1,Exp 9/16/19; S06162019DH@14, Exp 10/16/19; S06262019DT@03, Exp 10/26/19; S06262019DT@10, Exp 10/26/19; S07252019DH@11, Exp 11/25/19

Drugs

S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.

Class II

Lot #: S05162019DT@04, Exp 8/16/19;



Drugs

S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx

Class II

Lot #:S06092019DH@04, Exp 8/9/19;



Drugs

S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx

Class II

Lot #:S06092019DH@07, Exp 8/9/19; S06112019DH@03, Exp 8/11/19;S06122019DH@01, Exp 8/12/19;



Drugs

S-TRIMIX various strengths to include: a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML)

Class II

Lot #:a) S07162019DH@07, EXP. 9/16/19 b) S06242019DH@01, EXP 8/24/19; S07102019DT@15, EXP. 9/20/19; S07252019DH@03, EXP. 9/25/19; S07312019DH@1





Firm MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx

3, EXP. 9/31/19 c) S07102019DT@03, EXP. 9/10/19 d) S07262019DH@01, EXP. 9/26/19; S07232019DH@07, EXP. 9/23/19 e) S06262019DH@05, EXP. 8/26/19; S07132019DT@06, EXP. 9/13/19 f) S06162019DH@12, EXP. 8/16/19 g) S06252019DT@06, EXP. 8/25/19; S07032019DT@04, EXP. 9/3/19; S07102019DT@02, EXP. 9/10/19; h) S07172019dt@13, EXP. 9/17/19 i) S07032019DT@01, EXP. 9/3/19 j) S06092019DH@07, EXP. 8/9/19; S06112019DH@03, EXP. 8/11/19; S06122019DT@01, EXP. 8/12/19 k) S07022019DT@05, EXP. 9/2/19; S07132019DT@04, EXP. 9/13/19 l) S07022019DT@01, EXP. 9/2/19;



Firm S07302019DH@06, EXP. 9/30/19 m) S06252019DT@07, EXP. 8/25/19; n) S07022019DT@04, EXP. 9/2/19

Drugs

Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720

Class II

Batch Numbers: All lots within expiry.

CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc.

Drugs

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61), c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC

Class II




Drugs

Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC

Class II




Drugs

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC

Class II




Drugs

Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC

Class II




Drugs

Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)

Class II






Firm Drugs

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

Class II




Drugs

Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

Class II




Drugs

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.

Class II




Drugs

Ranitidine Tablets, USP 75 mg, NDC 57896-715-24 (GeriCare) OTC.

Class II




Drugs

Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.




Drugs

Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 5511-1130-30) b.) 100 count bottles (NDC 5511-1130-01)

Class II




Drugs

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

Class II




Drugs

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

Class II




Drugs

Ranitidine Tablets, USP 75 mg, a.) 30-count bottles (NDC 0363-0131-30), b.) 80-count

Class II


CGMP Deviations: Presence of NDMA impurity




Firm bottles (NDC 0363-0131-80) (Walgreens) OTC

detected in product.

Drugs

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

Class II




Drugs

Ranitidine Tablets, USP 150 mg, NDC 57896-717-05 (GeriCare) OTC

Class II




Drugs

Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075.

Class II

Lots: 120718, 072518, 112017, 120718

Marketed without an Approved NDA/ANDA

Basic Reset Inc.

Drugs

Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.

Class II

ALL


Basic Reset Inc.

Drugs

Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Class II

Lots: 28917A, 23918A, 21519A


Basic Reset Inc.

Drugs

Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075

Class II

Lot: 30995


Basic Reset Inc.

Drugs

Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Class II

Lots: 1902411.25, 1916911.25


Basic Reset Inc.

Drugs

Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic

Class II

Lots: 1902411.25, 1916911.25


Basic Reset Inc.



Firm Reset Hendersonville, TN 37075

Drugs

Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Class II

Lot: 1916911.25


Basic Reset Inc.

Drugs

Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Class II

Lot: 1903011.8


Basic Reset Inc.

Drugs

BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

Class II

Lots: 1902411.25


Basic Reset Inc.

Drugs

BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

Class II

Lot: 1903011.80


Basic Reset Inc.

Drugs

BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075

Class II

Lot: 1902411.25


Basic Reset Inc.

Drugs

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05

Class II

Lot #: 8082708, Exp. Date September 2020

Presence of Foreign Substance

Mylan Pharmaceuticals Inc.

Drugs

Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO

Class III

Lot #: TXWT, Exp 01/20; TXTS, Exp 10/20; AXWS, Exp 10/21

Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.

Sato Pharmaceutical Inc.



Firm PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.

Drugs

Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02

Class III

Lot #: F802436, F802437, F802438, F802442, Exp 11/20

Presence of Foreign substance: identified as a dead ant.

Lupin Pharmaceuticals Inc.

Drugs

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10

Class III

Lot #: F802345, F802346, F802347, Exp 11/20



Drugs

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

Class III

Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20



Drugs Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

Class III

Lot #: NBSB19001DA3, Exp. date 02/2021

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

AuroMedics Pharma LLC



Firm Drugs Testosterone Cypionate

Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01

Class III

lot# 23803.002B, Exp 07/2020; 23803.005A, Exp 01/2021

Labeling: Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials

Arbor Pharmaceuticals Inc.

Drugs Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

Class III

Lot #s: a) 290635FA, 290635FB, Exp. 11/30/2019; 293230F, Exp. 6/30/2020; 294628F, 301337F, Exp. 11/30/2020; 304451FA, Exp. 1/31/2021. b) 290636FA, 290636FB, 290636FC, Exp. 11/30/2019; 293233FA, 293233FB, Exp. 5/31/2020; 293234FA, 293234FB, Exp. 6/30/2020; 294630F,

Labeling: Incorrect or missing package insert.

Sandoz Inc



Firm 301338FA, 301338FB, 309426F, Exp. 11/30/2020; 304455FA, 304455FB Exp. 2/28/2021; 304883F, Exp. 4/30/2021; 312790F, Exp. 5/31/2021.

Drugs Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06

Class III

Lot #s: 287880F, 287881F, Exp. 10/31/2019; 290555F, Exp. 11/30/2019; 293389F, Exp. 2/29/2020; 290556F, 290557F, 293386F, 293387F, Exp. 3/31/2020; 293388F, 293390F, Exp. 5/31/2020; 293391F, Exp. 6/30/2020; 293392F, Exp. 7/31/2020; 295342F, 298823F, Exp. 8/31/2020; 295344F, 295345F, 295346F, Exp. 10/31/2020; 295347F, 304496F, Exp. 11/30/2020; 298825F, Exp. 12/31/2020; 304495F, 304497F, Exp.


Sandoz Inc



Firm 01/31/2021; 304963F, Exp. 3/31/2021; 304966F, Exp. 4/30/2021; 304964F, Exp. 5/31/2021.

Drugs Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.

Class III

Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020


Sandoz Inc

Drugs PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.

Class III

Lots: SU9079A, SU9079B, Exp 4/5/2020

Incorrect labeling: Incorrect or missing lot and/or exp date


Drugs Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8

Class III

Lot: RC5439 Exp. 03/2022

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

Apotex Inc.

*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm

http://www.fda.gov/Safety/Recalls/default.htm


CURRENT DRUG SHORTAGES

Losartan Tablets October 23, 2019 Reason for the Shortage

• Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan.

• Camber, Heritage, Teva, and Torrent been affected by the recall. • Alembic has losartan tablets available. • Aurobindo and Mylan refuse to provide updated availability information. • Cadista has temporarily discontinued losartan tablets due to issues with obtaining active

ingredient. • Lupin, Sandoz, and Zydus did not provide a reason for the shortage. • Major has losartan tablets in unit-dose packages available. • Merck has Cozaar available. • Rising discontinued losartan in August 2019. • Torrent recalled several lots of losartan tablet presentations due to an impurity found in the

active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium.

• Torrent has been unavailable to provide updated availability information. Estimated Resupply Date

• Alembic has losartan potassium 50 mg and 100 mg tablets on back order and the company estimates a release date of January 2020.

• Cadista has temporarily discontinued losartan potassium tablets and the company cannot estimate when product will be available again.

• Heritage has losartan potassium tablets on back order and the company cannot estimate a release date.

• Lupin has losartan potassium tablets on back order and the company cannot estimate a release date.

• Major has losartan potassium tablets on back order and the company cannot estimate a release date.

• Sandoz has losartan potassium tablets on back order and the company cannot estimate a release date.

• Teva has losartan potassium tablets on back order and the company cannot estimate a release date.

• Zydus has losartan potassium tablets on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=572


Bupivacaine Injection October 23, 2019 Reason for the Shortage

• AuroMedics has not provided a reason for the shortage. • Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product. • Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%

bupivacaine 30 mL glass ampules in December 2017. Estimated Resupply Dates

• Areva is temporarily importing 0.25% bupivacaine and 0.5% bupivacaine 5 mL and 10 mL ampules. FDA is allowing temporary importation of product from Italy manufactured by Areva's supplier, Fisiopharma. Details on how to obtain product and differences between the US and Italian labeling can be found at: http://arevapharma.com/wp-content/uploads/2019/09/Dear-Health-Care-Provider-Letter-final.pdf.

• AuroMedics has 0.5% bupivacaine 30 mL preservative-free vials on intermittent back order and the company is releasing product as it becomes available. The 0.75% bupivacaine 10 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available.

• Fresenius Kabi has 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs on back order and the company cannot estimate release dates.

• Pfizer has 0.25% bupivacaine 10 mL preservative-free vials on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine 30 mL preservative-free vials are available in limited supply. The 0.5% bupivacaine 50 mL vials are available in limited supply. The 0.75% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of December 2019.

• Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of April 2020 for the 10 mL vials and November 2019 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5% 50 mL vials are on back order and the company estimates a release date of December 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020 for the 10 mL vials and November 2019 for the 30 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172 Atropine Sulfate Ophthalmic Ointment October 23, 2019 Reason for the Shortage

• Bausch Health did not provide a reason for the shortage. Estimated Resupply Date

• Bausch Health has atropine sulfate ointment on back order and the company estimates a release date of early-January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172


Mineral Oil and Petrolatum Ophthalmic Ointment October 24, 2019 Reason for the Shortage

• Allergan states the shortage is due to production delays. The Lacri-Lube SOP 7 gram tubes have been discontinued.

• Bausch Health has Soothe Night Time ointment available. • Major did not provide a reason for the shortage. • Alcon states the shortage is due to manufacturing issues and increased demand. • Perrigo discontinued Puralube ointment products in early-2019. • Rugby discontinued Artificial Tears 3.5 gram tubes in January 2019.

Estimated Resupply Dates • Alcon has Genteal PM ointment on intermittent back order with regular releases. • Major has Lubrifresh PM 3.5 gram tubes on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435 Diltiazem Hydrochloride Injection October 24, 2019 Reason for the Shortage

• Akorn states the reason for the shortage was increased demand due to market conditions. They are not currently producing the 25 mL vials in 10 count.

• Pfizer states the reasons for the shortage is manufacturing delays and increases in demand. • Hikma has diltiazem injection on shortage due to manufacturing delays caused by increased

demand due to current market conditions. Estimated Resupply Dates

• Hikma has diltiazem 5 mg/mL 25 mL vials on back order and the company estimates a release date of early-November 2019.

• Pfizer has 100 mg ADD-Vantage vials available in limited supply. The 5 mg/mL 5 mL vials are on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Bumetanide Injection October 24, 2019 Reason for the Shortage

• Pfizer has bumetanide injection on shortage due to manufacturing delays. • Hikma has bumetanide injection available.

Estimated Resupply Dates • Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on back order and the company

estimates a release date of December 2019. • Hikma has bumetanide 0.25 mg/mL 4 mL vials on allocation.



Bivalirudin Injection October 24, 2019 Reason for the Shortage

• Accord has temporarily discontinued bivalirudin. • Apotex has discontinued bivalirudin. • AuroMedics did not provide a reason for the shortage. • Baxter has 250 mg/50 mL bivalirudin premixed bags available. The company is not actively

producing the 500 mg/100 mL bags due to low demand. • Dr. Reddy's has bivalirudin available. • Fresenius Kabi did not provide a reason for the shortage. • Pfizer has bivalirudin on shortage due to manufacturing delays. • Sandoz has bivalirudin available.

Estimated Resupply Dates • AuroMedics has bivalirudin 250 mg vials on allocation. • Pfizer has bivalirudin 250 mg vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=569 Thrombin Topical Powder (Recombinant) October 25, 2019 Reason for the Shortage

• Baxter did not provide a reason for the shortage. Estimated Resupply Dates

• Baxter has Recothrom 20,000 unit pump spray kits on back order and the company estimates a release date of early-December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=499 Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution October 29, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Altaire is not currently marketing polyvinyl alcohol 1.4% ophthalmic solution. • Major has Liquitears on shortage because they are updating the NDC number. • Ocusoft has Tears again on shortage because the product was recalled. • Rugby has Artificial Tears solution on shortage because they are updating the NDC number.

Estimated Resupply Dates • Akorn has Artificial Tears Solution ophthalmic drops on allocation. • Major has Liquitears ophthalmic drops temporarily discontinued and the company cannot

estimate a release date. • Rugby has Artificial Tears solution temporarily discontinued and the company cannot estimate a

release date. • Ocusoft has Tears Again solution on back order and the company cannot estimate a release

date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=451


Orphenadrine Citrate Injection October 29, 2019 Reason for the Shortage

• Akorn has orphenadrine injection available. • Hikma has orphenadrine injection available. • Teva discontinued orphenadrine in November 2018.

Estimated Resupply Dates • N/A

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=471 Lorazepam Tablets October 29, 2019 Reason for the Shortage

• Aurobindo refuses to provide availability information. • Leading has lorazepam tablet presentations available. • Major did not provide a reason for the shortage. • Mylan has discontinued all bottled presentations. • Mylan Institutional discontinued all unit-dose blister pack presentations. • Sandoz discontinued all lorazepam presentations. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Bausch Health has Ativan 1 mg tablets on back order and the company cannot estimate a

release date. • Major has all lorazepam tablet presentations on back order and the company estimates a

release date of late-November 2019. • Teva has lorazepam 0.5 mg tablets, 1 mg tablets, and 2 mg tablets in 100 count bottles on back

order and the company estimates a release date of late-October to early-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=480 Fluticasone and Salmeterol Powder for Inhalation October 29, 2019 Reason for the Shortage

• Teva Respiratory did not provide a reason for the shortage. • Other fluticasone and salmeterol dry powder inhalers are not affected by the shortage.

Estimated Resupply Dates • Teva Respiratory has AirDuo Respiclick 232 mcg/14 mcg and 113 mcg/14 mcg inhalers on back

order and the company estimates a release date of early-November 2019. • Teva Respiratory has fluticasone 113 mcg/salmeterol 14 mcg on back order and the company

estimates a release date of late-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=544


Disulfiram Tablets October 29, 2019 Reason for the Shortage

• Alvogen has the product on shortage due to increased demand. • TEVA did not provide a reason for the shortage. • Mylan discontinued disulfiram tablets. • Rising Pharmaceuticals discontinued disulfiram tablets.

Estimated Resupply Dates • Alvogen has disulfiram 250 mg tablets on back order and the company estimates a release date

of mid-November 2019. • Teva has disulfiram 250 mg and 500 mg tablets on back order and the company cannot estimate

a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=601 Cyclosporine Injection October 29, 2019 Reason for the Shortage

• Novartis has Sandimmune available. • Perrigo has cyclosporine injection available.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=534 Ciprofloxacin Ophthalmic Solution October 29, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Novartis has Ciloxan available. • Sandoz has ciprofloxacin ophthalmic solution available.

Estimated Resupply Dates • Akorn has ciprofloxacin ophthalmic solution on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=443 Argatroban Injection October 29, 2019 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Chiesi did not provide a reason for the shortage. • Fresenius Kabi has argatroban available. • Hikma did not provide a reason for the shortage. • Mylan Institutional did not provide a reason for the shortage. • Par has argatroban available. • Pfizer has argatroban on shortage due to manufacturing delay. • Sandoz discontinued argatroban 1 mg/mL 50 mL vials in April 2019.


• Teva has argatroban temporarily unavailable. Estimated Resupply Dates

• AuroMedics has argatroban 1 mg/mL 50 mL vials on intermittent back order. • Chiesi has argatroban 1 mg/mL 50 mL vials on back order and the company cannot estimate a

release date. • Mylan has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a

release date in mid- to late-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=494 Bisoprolol Fumarate Tablets October 30, 2019 Reason for the Shortage

• Mylan discontinued bisoprolol tablets in April 2019. • Unichem Pharmaceuticals had product on shortage due to market demand.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=512 Rabies Vaccine October 31, 2019 Reason for the Shortage

• GlaxoSmithKline did not provide a reason for the shortage. Estimated Resupply Dates

• GlaxoSmithKline has RabAvert rabies vaccine available to direct purchasing customers. The company estimates a release date of early-November 2019 for back orders from wholesaler and distributor orders.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=594 Cyclosporine Oral Solution October 31, 2019 Reason for the Shortage

• Teva has cyclosporine oral solution on shortage due to an active pharmaceutical ingredient delay.

Estimated Resupply Dates • TEVA has cyclosporine modified oral solution on back order and the company estimates a

release date of early-January 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=596 Venlafaxine Hydrochloride Extended-Release Capsules November 1, 2019 Reason for the Shortage

• Teva and Zydus did not provide a reason for the shortage. • Pfizer has Effexor XR capsules available. • Zydus has discontinued the 30 count presentations.

Estimated Resupply Dates


• Teva has venlafaxine 37.5 mg, 75 mg, and 150 mg extended-release capsules in 30-, 90-, and 500-count bottles on intermittent back order and the company is releasing product as it becomes available. The venlafaxine 37.5 mg capsules in 30-count bottles are available in limited supply.

• Zydus has all venlafaxine extended-release capsule presentations on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=587 Prednisone Oral Tablets November 1, 2019 Reason for the Shortage

• Cadista, Hikma, and Par did not provide a reason for the shortage. • Teva has prednisone 5 and 10 mg tablets in 21 and 48 count packaging on shortage due to

manufacturing delays. Estimated Resupply Dates

• Cadista has all prednisone tablet presentations on allocation. • Hikma has most prednisone tablet presentations on allocation. • Par has prednisone 20 mg tablets in 1000 count bottles on back order and the company

estimates a release date of mid-December 2019. • Teva has prednisone 10 mg tablets in 48 count bottles on back order and the company

estimates a release date of early-November 2019. Prednisone 5 mg 21 and 48 count bottles, prednisone 10 mg 21 and 1000 count bottles, and prednisone 20 mg 100 and 500 count bottles are on back order and the company estimates a release date of mid-November 2019. Prednisone 5 mg 1000 count bottles, and 20 mg 500 and 1000 count bottles are on back order and the company estimates a release date in late-December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=563 Losartan and Hydrochlorothiazide Tablets November 1, 2019 Reason for the Shortage

• Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan.

• Alembic did not provide a reason for the shortage. • Aurobindo refused to provide updated availability information • Cadista did not provide a reason for the shortage. • Lupin did not provide a reason for the shortage. • Merck has Hyzaar tablets available. • Rising did not provide a reason for the shortage. • Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg tablets in 1000 count

bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm.

• Torrent recalled several lots of losartan and hydrochlorothiazide tablet presentations due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium.

• Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall).

• Teva did not provide a reason for the shortage. Estimated Resupply Dates

• Alembic has losartan and hydrochlorothiazide tablets on allocation to contracted customers • Cadista discontinued all losartan and hydrochlorothiazide tablets. • Lupin has losartan and hydrochlorothiazide tablets on back order and the company cannot

estimate a release date. • Rising discontinued all losartan and hydrochlorothiazide tablets. • Sandoz has losartan and hydrochlorothiazide tablet presentations on back order and the

company cannot estimate a release date. • Teva has all losartan and hydrochlorothiazide tablets on back order and the company estimates

release dates in late-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=529 Vincristine Sulfate Injection November 4, 2019 Reason for the Shortage

• Pfizer has vincristine on shortage due to manufacturing delays and increased demand. They are the sole supplier of vincristine sulfate injection. There is a Dear Healthcare Professional letter available at https://www.fda.gov/media/131865/download.

• Teva discontinued Vincosar in early-July 2019. Estimated Resupply Dates

• Pfizer has vincristine 1 mg/mL 1 mL and 2 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=600 Sufentanil Injection November 4, 2019 Reason for the Shortage

• Akorn had Sufenta injection on shortage due to increased demand for the product. • Hikma stopped marketing sufentanil injection in October 2018. • Pfizer has sufentanil injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Akorn has Sufenta 0.5 mg/mL 5 mL ampules on allocation. • Pfizer has sufentanil 0.5 mg/mL 1 mL, 2 mL, and 5 mL vials on back order and the company

estimates a release date of November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=376 Rocuronium Injection November 4, 2019 Reason for the Shortage

• Athenex has rocuronium available. • AuroMedics did not provide a reason for the shortage.


• Fresenius Kabi has rocuronium available. • Mylan Institutional refused to provide availability information. • Pfizer has rocuronium on shortage due to manufacturing delays. • Sagent has rocuronium available. • Sandoz has rocuronium available. • X-Gen has rocuronium available.

Estimated Resupply Dates • AuroMedics has rocuronium 10 mg/mL 5 mL vials on intermittent back order and the company

is releasing product as it becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290 Epinephrine Injection November 4, 2019 Reason for the Shortage

• Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.

• Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017. • BPI has epinephrine 1 mg/mL 2 mL ampules available. • Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.

Estimated Resupply Dates • Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation. • Pfizer has epinephrine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company

estimates a release date of November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Doxycycline Hyclate Injection November 4, 2019 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • Zydus discontinued doxycycline injection in mid-2019. • Fresenius Kabi did not provide a reason for the shortage.

Estimated Resupply Dates • Fresenius Kabi has doxycycline 100 mg vials on back order and the company estimates a release

date of mid- to late-November 2019. • Mylan Institutional has doxycycline 100 mg vials on back order and the company estimates a

release date of late-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=559 Dopamine Hydrochloride Injection November 4, 2019 Reason for the Shortage

• American Regent is not marketing dopamine injection. • Baxter has dopamine premixed bags available.


• Pfizer states the shortage is due to manufacturing delays. The dopamine 200 mg/250 mL and 400 mg/500 mL premixed bags were discontinued in August 2017.

Estimated Resupply Dates • Pfizer has dopamine 40 mg/mL 10 mL vials on back order and the company estimates a release

date of June 2020. The 800 mg/250 mL premixed bags are on back order and the company estimates a release date of November 2019. The 40 mg/mL 5 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=246 Dobutamine Injection November 4, 2019 Reason for the Shortage

• Baxter has dobutamine available. • Pfizer has dobutamine on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an

estimated release date of March 2020 for the 20 mL vials and December 2019 for the 40 mL vials.

• Pfizer has dobutamine 4 mg/mL in 250 mL bags on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296 Copper Chloride Injection November 4, 2019 Reason for the Shortage

• Pfizer had copper chloride on shortage due to manufacturing delays. They are the sole supplier of copper chloride.

Estimated Resupply Dates • Pfizer has copper chloride available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=553 Chlorothiazide Oral Tablets and Suspension November 4, 2019 Reason for the Shortage

• Mylan discontinued chlorothiazide tablets in September 2019. • Hikma discontinued chlorothiazide tablets. • Bausch health did not provide a reason for the shortage.

Estimated Resupply Dates • Bausch Health has Diuril chlorothiazide suspension on back order and the company estimates a

release date of early-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=607


Cefuroxime Sodium Injection November 4, 2019 Reason for the Shortage

• Sagent had cefuroxime injection on shortage due to manufacturing delays and increased demand.

• Teligent discontinued all Zinacef presentations in February 2018. • Hikma did not provide a reason for the cefuroxime injection shortage. They are not currently

marketing the 7.5 gram vials. Estimated Resupply Dates

• Sagent has cefuroxime 750 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13 Calcium Chloride Injection November 4, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Amphastar has calcium chloride on shortage due to increased demand. • Medefil launched calcium chloride 10 mL syringes in early-November 2019. • Mylan Institutional has withdrawn calcium chloride syringes from the market. The company

recalled the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.

• Pfizer has calcium chloride on shortage due to manufacturing delays. Estimated Resupply Dates

• Amphastar has calcium chloride 100 mg/mL 10 mL syringes on allocation. • Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes on back order and the company

estimates a release date of December 2019. The 100 mg/mL 10 mL LifeShield syringes are on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 Atropine Sulfate Injection November 4, 2019 Reason for the Shortage

• American Regent had atropine injection on shortage due to market demand. • Amphastar has atropine injection on shortage due to increased demand. • Fresenius Kabi has atropine injection available. • Hikma has atropine injection available. • Pfizer has atropine injection on shortage due to manufacturing delays.

Estimated Resupply Dates • American Regent has atropine 0.4 mg/mL 1 mL vials and 1 mg/mL 1 mL vials available in limited

supply. • Hikma has short-dated atropine 0.4 mg/mL 20 mL vials available with an expiration date of June

2020. • Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company

estimates release dates of November 2019. The 0.1 mg/mL 10 mL Ansyr syringes are on back order and the company estimates a release date of December 2019. The 0.1 mg/mL 5 mL


LifeShield syringes are on back order and the company estimates release dates of November 2019. The 0.05 mg/mL 5 mL Ansyr syringes are available with an expiration date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 50% Dextrose Injection November 4, 2019 Reason for the Shortage

• Amphastar has 50% dextrose injection on allocation due to increased demand. • Pfizer has 50% dextrose injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has 50% dextrose 50 mL LifeShield syringes on back order and the company estimates a

release date of November 2019. The 50% dextrose 50 mL Ansyr syringes are on back order and the company estimates a release date of November 2019. The 50% dextrose 50 mL vials are on back order and the company estimates a release date of December 2019.

• Amphastar has 50% dextrose 50 mL Luer-Jet syringes on allocation with regular releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 Sodium Phosphate Injection November 5, 2019 Reason for the Shortage

• American Regent is not currently marketing sodium phosphate injection. • Fresenius Kabi has sodium phosphate injection available. • Pfizer has sodium phosphate injection on shortage due to manufacturing delay.

Estimated Resupply Dates • Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates

a release date of March 2020 https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Potassium Acetate Injection November 5, 2019 Reason for the Shortage

• American Regent has not had product available for several years. It is unclear if they will market potassium acetate again in the future.

• Pfizer has potassium acetate on shortage due to manufacturing delays. • Exela has potassium acetate on allocation to prevent hoarding.

Estimated Resupply Dates • Exela has potassium acetate 2 mEq/mL 20 mL vials on allocation. • Pfizer has potassium acetate 2 mEq/mL 20 mL and 50 mL vials available in limited supply.



Olanzapine Intramuscular Injection November 5, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Lilly has Zyprexa intramuscular injection available. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=492 Aspirin Suppositories November 5, 2019 Reason for the Shortage

• Perrigo has aspirin suppositories on shortage due to manufacturing delays. Estimated Resupply Dates

• Perrigo has aspirin 300 mg and 600 mg suppositories on back order and the company estimates a release date of mid-November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=568 14.6% Sodium Chloride Concentrated Solution for Injection November 5, 2019 Reason for the Shortage

• Pfizer has 14.6% sodium chloride concentrated solution for injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has 14.6% sodium chloride concentrated solution for injection 20 mL vials on back order

and the company estimates a release date of March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=416 Vancomycin Hydrochloride Injection November 6, 2019 Reason for the Shortage

• Alvogen has vancomycin injection available. • Athenex has vancomycin injection available. • AuroMedics did not provide a reason for the shortage. • Pfizer has vancomycin vials on back order due to manufacturing delays. • Fresenius Kabi has vancomycin injection available. • Mylan Institutional has vancomycin injection available. • Baxter has vancomycin injection available. • Samson Medical Technologies has vancomycin injection available. • Sagent has vancomycin injection available. • Xellia Pharmaceuticals has vancomycin injection and vancomycin premixed bags available.

Estimated Resupply Dates • AuroMedics has vancomycin 1 gram vials on long-term back order and the company cannot

estimate a release date.


• Pfizer has vancomycin 750 mg ADD-Vantage vials on back order and the company estimates a release date of March 2020. The 500 mg ADD-Vantage vials are available with short expiration dating (December 2019). The 1 gram ADD-Vantage vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Labetalol Injection November 6, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Alvogen did not provide a reason for the shortage. • Fosun has labetalol injection available. • Hikma has labetalol injection on shortage due to increase demand. • Pfizer has labetalol injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Hikma has labetalol 5 mg/mL 20 mL and 40 mL vials on allocation • Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a

release date of November 2019 for the 20 mL vials and January 2021 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Guanfacine Hydrochloride Tablets November 6, 2019 Reason for the Shortage

• Amneal has guanfacine tablets available. • Mylan did not provide a reason for the shortage. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has guanfacine 2 mg tablets in 100 count bottles on back order and the company cannot

estimate a release date. • Mylan has guanfacine 1 mg and 2 mg tablets in 100 count bottle on back order and the company

estimates a release date of mid-January 2020 https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=508 Fluvastatin Capsules November 6, 2019 Reason for the Shortage

• Mylan has fluvastatin capsules available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has fluvastatin 20 mg and 40 mg capsules in 100 count on back order and the company

estimates a release date of late-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=561


Doxorubicin Injection November 6, 2019 Reason for the Shortage

• Hikma has Adriamycin available. • Teva had doxorubicin solution for injection on shortage due to increased demand. They

discontinued doxorubicin presentations with NDCs starting in 00703 in early-January 2019. • Fresenius Kabi has doxorubicin available. • Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials. • Pfizer has doxorubicin on shortage due to manufacturing delays. • Sagent has doxorubicin available. • Mylan Institutional discontinued doxorubicin 10 mg lyophilized powder for injection in early

2019. The 50 mg vials are available. • Athenex has doxorubicin available. • FDA was allowing temporary importation of doxorubicin lyophilized powder for injection 50 mg

vials. These vials were manufactured for Hospira UK Limited. The labeling as well as bar coding for the imported product is different from the US version. FDA has the Dear Healthcare Professional Letter linked on their website. The letter includes a link to both the US and United Kingdom package inserts to help explain the differences in labeling and packaging. The link to the letter is http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM507498.pdf. Ordering can be done directly with Hospira Customer Care at 877-946-7747.

Estimated Resupply Dates • Hikma has doxorubicin 2 mg/mL 100 mL vials on back order and the company estimates a

release date of late-November. • Pfizer has doxorubicin 2 mg/mL 75 mL vials on back order and the company estimates a release

date of November 2019. • Teva has doxorubicin 2 mg/mL 25 mL vials on intermittent back order and is allocating product

upon release.2 https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108 Dicyclomine Oral Presentations November 6, 2019 Reason for the Shortage

• Hikma has dicyclomine capsules and tablets available. • Lannett has dicyclomine capsules and tablets available. • Mylan did not provide a reason for the shortage. • Par Pharmaceuticals has dicyclomine oral solution available. • Teva has dicyclomine capsules and tablets available.

Estimated Resupply Dates • Mylan has dicyclomine 10 mg capsules in 100 count and 500 count on back order and the

company estimates a release date of late-December 2019. The 20 mg tablets in 500 count are on back order and the company estimates a release date of late-January 2020.



Diclofenac Potassium Tablets November 6, 2019 Reason for the Shortage

• Mylan has diclofenac potassium tablets available. • Teva did not provide a reason for the shortage. • Sandoz discontinued diclofenac potassium tablets.

Estimated Resupply Dates • Teva has diclofenac potassium 50 mg tablets in 100 count and 500 count on back order and the

company estimates a release date of mid-December 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=537 Desiccated Thyroid Tablets November 6, 2019 Reason for the Shortage

• Acella has NP Thyroid available. • Allergan has Armour Thyroid available. • RLC states the reason for the shortage is increased demand and difficulty obtaining raw

materials. Estimated Resupply Dates

• RLC has Nature-Throid 16.25 mg, 194.4 mg, 260 mg, and 325 mg tablets on back order and the company cannot estimate a release date. Westhroid presentations are also on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=350 Cefoxitin Sodium Injection November 6, 2019 Reason for the Shortage

• Apotex has temporarily discontinued cefoxitin vials. • BBraun has cefoxitin on allocation due to increased demand. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. Hikma is not currently marketing cefoxitin 10

gram vials. • Sagent has cefoxitin on shortage due to increased demand and manufacturing delay. • WG Critical Care did not provide a reason for the shortage.

Estimated Resupply Dates • Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the

company cannot estimate when product will be available again. • BBraun has cefoxitin 1 gram and 2 gram DUPLEX bags on back order and the company cannot

estimate a next release date. • Fresenius Kabi has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a

release date of mid-December 2019 for the 1 gram vials and early-January 2020 for the 2 gram vials.

• Hikma has cefoxitin 1 gram vials on back order and the company estimates a release date of late-November 2019. The 2 gram vials are on allocation. The 10 gram vials are on back order and the company estimates a release date of mid- to late-January 2020.


• Sagent has cefoxitin 1 gram and 2 gram vials on allocation. The 10 gram vials are on back order and the company estimates a release date of November 2019.

• WG Critical Care has cefoxitin 1 gram, 2 gram, and 10 gram vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Bacitracin Ophthalmic Ointment November 6, 2019 Reason for the Shortage

• In early-July 2019, Altaire recalled several lots of certain ophthalmic ointments, including bacitracin ophthalmic ointment. The products were recalled due to a potential for nonsterility. Additional information, including the specific lots affected, is available at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products.

• Altaire manufactures bacitracin ophthalmic ointment and Perrigo distributes the product. Estimated Resupply Dates

• Perrigo has bacitracin ophthalmic ointment 3.5 gram tubes on back order and the company estimates a release date of late-December 2019 to early-January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=582 Alprostadil Urethral Suppositories November 6, 2019 Reason for the Shortage

• Mylan did not provide a reason for the shortage. Estimated Resupply Dates

• Mylan has Muse suppositories on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=605 5% Dextrose Injection (PVC-free and DEHP-free) November 6, 2019 Reason for the Shortage

• Baxter has 5% dextrose PVC/DEHP-free Viaflo bags available. • BBraun had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays. • BD has 5% dextrose PVC/DEHP-free bags available. • Fresenius Kabi has 5% dextrose PVC/DEHP-free bags available. • ICU Medical had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=314 Vecuronium Bromide Injection November 7, 2019 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Pfizer had vecuronium on shortage due to manufacturing delays.


• Teva has vecuronium available. • Pfizer sold vecuronium injection to Mylan Institutional in December 2013. • Mylan Institutional has vecuronium available. • Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014. • Sun Pharma has vecuronium available. • Sagent is not marketing vecuronium 10 mg and 20 mg vials. • Fresenius Kabi has vecuronium available.

Estimated Resupply Dates • AuroMedics has vecuronium 10 mg and 20 mg vials on intermittent back order and the company

is releasing product as it becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167 Secobarbital Capsules November 7, 2019 Reason for the Shortage

• Bausch Health is the sole supplier of secobarbital capsules. The company states that Seconal capsules are on back order due to a short-term stock out.

Estimated Resupply Dates • Bausch Health has Seconal (secobarbital) 100 mg capsules on back order and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=517 Meperidine Hydrochloride Injection November 7, 2019 Reason for the Shortage

• Pfizer has Demerol injection on shortage due to manufacturing delays. • ICU Medical discontinued meperidine 30 mL PCA vials.

Estimated Resupply Dates • Pfizer has Demerol 25 mg/mL 1 mL Carpuject syringes, 50 mg/mL 1 mL Carpuject syringes, 75

mg/mL 1 mL Carpuject syringes, 100 mg/mL 1 mL Carpuject syringes, 50 mg/mL 1 mL and 1.5 mL ampules, and 100 mg/mL 1 mL ampules and 20 mL vials on back order and the company estimates a release date of October 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=347 Furosemide Injection November 7, 2019 Reason for the Shortage

• American Regent is not actively marketing furosemide injection. • Amneal discontinued furosemide injection. • Baxter has furosemide injection available. • Fresenius Kabi did not provide a reason for the shortage. • Heritage did not provide a reason for the shortage. • Pfizer had furosemide injection on shortage due to manufacturing delays and increased

demand. Estimated Resupply Dates


• Fresenius Kabi has furosemide 10 mg/mL 10 mL vials on back order and the company estimates a release date of late-November 2019.

• Heritage has short-dated furosemide 10 mg/mL 2 mL vials available with an expiration date of June 2020.

• Pfizer has furosemide 10 mg/mL 4 mL and 10 mL syringes on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323 Acetylcysteine Oral and Inhalation Solution November 7, 2019 Reason for the Shortage

• American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

• Arbor discontinued Cetylev effervescent tablets in April 2019. • Fresenius Kabi has acetylcysteine oral and inhalation solution available. • Pfizer has acetylcysteine oral and inhalation solution available. • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.

Estimated Resupply Dates • American Regent has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the

company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43 Tropicamide 1% Ophthalmic Solution November 8, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage of tropicamide 1% ophthalmic drops. • Alcon has Mydriacyl available. • Bausch Health discontinued tropicamide 1% ophthalmic drops in mid-2018. • Sandoz did not provide a reason for the shortage of tropicamide 1% ophthalmic drops.

Estimated Resupply Dates • Sandoz has 1% tropicamide 3 mL bottles on back order and the company estimates a release

date of early-January 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=547 Tacrolimus-Extended Release Capsules and Tablets November 8, 2019 Reason for the Shortage

• Astellas has Astagraf XL capsules on allocation. Estimated Resupply Dates

• Astellas has Astagraf XL available on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=595


Nalbuphine Injection November 8, 2019 Reason for the Shortage

• Pfizer has nalbuphine on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has all nalbuphine presentations on back order and the company estimates a release date of June 2020. There are short-dated 10 mg/mL 10 mL vials available with an expiration date of January 2020. There are short-dated 20 mg/mL 10 mL vials available with an expiration date of February 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=599 Levetiracetam Injection November 8, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Athenex did not provide a reason for the shortage. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has product available. • Mylan has levetiracetam injection available. • Pfizer did not provide a reason for the shortage. • Sagent has product available. • Sun Pharma did not provide a reason for the shortage. • UCB has product available. • Hikma did not provide a reason for the shortage. • X-Gen has product available.

Estimated Resupply Dates • Athenex has levetiracetam 10 mg/mL and 15 mg/mL 100 mL premixed bags on allocation. • AuroMedics has levetiracetam 100 mg/mL 5 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Hikma has 100 mg/mL 5 mL vials on back order and the company estimates a release date of

mid-November 2019. • Pfizer has levetiracetam 100 mg/mL 5 mL vials on back order and the company estimates a

release date of November 2019. • Sagent has levetiracetam 100 mg/mL 5 mL vials available with short expiration dating (March

2020). • Sun Pharma has levetiracetam 100 mg/mL 5 mL vials on back order and the company cannot

estimate a release date. • X-Gen has levetiracetam 100 mg/mL 5 mL vials on back order and the company estimates a

release date of early-December 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=84


Levetiracetam Extended-Release Tablets November 8, 2019 Reason for the Shortage

• Lupin did not provide a reason for the shortage. • OWP is discontinuing their Roweepra XR formulations. • Sun Pharma did not provide a reason for the shortage. • Torrent is not selling their levetiracetam extended-release tablets within the US.

Estimated Resupply Dates • Apotex has levetiracetam extended-release 500 mg and 750 mg tablets on allocation. • Lupin has levetiracetam extended-release 500 mg tablets on intermittent back order and the

company is releasing product as it becomes available. The 750 mg extended-release tablets are on allocation.

• Sun Pharma has levetiracetam extended-release 500 mg and 750 mg tablets on intermittent back order and the company is shipping product as it becomes available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=583 Hydroxyzine Pamoate Oral Capsules November 8, 2019 Reason for the Shortage

• Amneal did not provide a reason for the shortage. • Heritage did not provide a reason for the shortage. • Mylan discontinued hydroxyzine pamoate capsules in May 2019. • Pfizer did not provide a reason for the shortage. • Rising discontinued hydroxyzine pamoate capsules. • Sandoz has hydroxyzine pamoate capsules available. • Teva has hydroxyzine pamoate capsules available.

Estimated Resupply Dates • Amneal has hydroxyzine pamoate 25 mg capsules in 100 count bottles on intermittent back

order and the company is releasing product as it becomes available. • Heritage has hydroxyzine pamoate 25 mg capsules in 100 count and 500 count and 50 mg

capsules in 100 count and 500 count on allocation. • Teva has hydroxyzine pamoate 25 mg capsules in 100 count and 500 count and 50 mg capsules

in 100 count and 500 count on back order and the company estimates a release date of mid-November 2019.

• Pfizer has Vistaril 25 mg and 50 mg capsules in 100 count bottles on back order and the company estimates a release date of late-November 2019 for the 25 mg capsules and cannot estimate a release date for the 50 mg capsules.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=545 Hydromorphone Hydrochloride Injection November 8, 2019 Reason for the Shortage

• Akorn has hydromorphone injection on shortage due to increased demand. • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing

their product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018.


• Pfizer did not provide a reason for the shortage. • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons. • Teva did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has hydromorphone injection on shortage due to increased demand. • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing

their product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018. • Pfizer did not provide a reason for the shortage. • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons. • Teva did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Fluorescein Sodium Ophthalmic Strips November 8, 2019 Reason for the Shortage

• Hub has Bio-Glo available. • Akorn did not provide a reason for the shortage

Estimated Resupply Dates • Akorn has Ful-Glo 0.6 mg and 1 mg strips on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=362 Fluconazole Injection November 8, 2019 Reason for the Shortage

• Baxter has fluconazole injection available. • Hikma discontinued fluconazole injection in August 2018. • Pfizer has fluconazole injection available. The 200 mg/100 mL fluconazole in dextrose bags were

discontinued in August 2018. • Renaissance Lakewood Pharmaceuticals bought fluconazole in sodium chloride premixed bags

from Claris Lifescience. • Sagent had fluconazole injection available.

Estimated Resupply Dates • Renaissance Lakewood has all fluconazole presentations on back order and the company cannot

estimate release dates. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=318 Etomidate Injection November 8, 2019 Reason for the Shortage

• American Regent is not currently marketing etomidate. • Athenex did not provide a reason for the current shortage. • AuroMedics did not provide a reason for the current shortage.


• Hikma has etomidate available. • Mylan Institutional has etomidate available. • Par Sterile Products discontinued etomidate in early 2015. • Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate

ampules in October 2016. • Sagent is no longer marketing etomidate. • Zydus did not provide a reason for the shortage.

Estimated Resupply Dates • Athenex has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company cannot

estimate a release date. • AuroMedics has etomidate 2 mg/mL 10 mL and 20 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Pfizer has Amidate 2 mg/mL 10 mL vials on back order and the company estimates a release

date of December 2019. The 20 mL vials are available in limited supply. The 2 mg/mL 20 mL LifeShield syringes on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147 Erythromycin Ophthalmic Ointment November 8, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Bausch Health did not provide a reason for the shortage. • Perrigo had erythromycin ophthalmic ointment on shortage due to increased demand.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540 Bisacodyl Suppositories November 8, 2019 Reason for the Shortage

• G&W Laboratories discontinued bisacodyl suppositories. • Major has bisacodyl suppositories on shortage due to increased demand. Major updated their

NDC numbers in September 2019. • Perrigo has bisacodyl suppositories available. • Rugby Laboratories has bisacodyl suppositories on shortage due to increased demand. Rugby

updated their NDC numbers in September 2019. Estimated Resupply Dates

• Major has bisacodyl 10 mg suppositories in 12 count and 100 count available. • Rugby Laboratories has bisacodyl 10 mg suppositories in 100 count available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=565 Benztropine Mesylate Injection November 8, 2019 Reason for the Shortage

• Akorn did not provide a reason for the shortage.


• Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has benztropine 1 mg/mL 2 mL ampules and Cogentin 1 mg/mL 2 mL ampules on back

order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=497 Atropine Ophthalmic Solution November 8, 2019 Reason for the Shortage

• Akorn did not provide a reason for the atropine ophthalmic solution shortage. • Altaire has homatropine ophthalmic solution available


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=514 Yellow Fever Vaccine November 11, 2019 Reason for the Shortage

• Sanofi Pasteur states the shortage of YF-Vax is due to production delays. • There are no other suppliers of yellow fever vaccine. • Additional information on the yellow fever shortage is available at

http://wwwnc.cdc.gov/travel/news-announcements/yellow-fever-vaccine-shortage-2015. Estimated Resupply Dates

• Sanofi Pasteur has YF-Vax multi-dose vials and single dose vials on back order and the company does not expect product to return to market in 2019. The company will release additional information regarding YF-Vax availability in 4th quarter 2019.

• FDA accepted an investigational new drug application in October 2016. This is for the importation of another yellow fever vaccine from France. The trade name of the imported product is Stamaril. The product information can be found at https://s3.amazonaws.com/filecache.drivetheweb.com/mr5str_sanofipasteur/202281/969800.pdf. The initial rollout began in April 2017. More information can be found at https://www.cdc.gov/mmwr/volumes/66/wr/mm6617e2.htm?s_cid=mm6617e2_w or at https://www.vaccineshoppe.com/index.cfm?fa=anon.content&n=YellowFever&title=.

• Stamaril is on allocation due to supply demand. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=197 Vinblastine Sulfate Injection November 11, 2019 Reason for the Shortage

• Fresenius Kabi has vinblastine on shortage due to a short-term manufacturing delay. They are the sole suppliers of vinblastine.

Estimated Resupply Dates • Fresenius Kabi has vinblastine available for direct and drop ship orders. The company estimates

the next release date of late-December 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=578


Ulipristal Acetate November 11, 2019 Reason for the Shortage

• Afaxys did not provide a reason for the shortage. Estimated Resupply Dates

• Afaxys has Ella 30 mg single-dose packets on back order and the company estimates a release date of mid-November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=609 Ketorolac Injection November 11, 2019 Reason for the Shortage

• Alvogen did not provide a reason for the shortage. • Amphastar did not provide a reason for the shortage. • Athenex has ketorolac available. • BD RX is now part of Fresenius Kabi. • Fresenius Kabi has most ketorolac presentations available. • Fosun Pharma has ketorolac available. • Pfizer has ketorolac injection on back order due to manufacturing delays. • Sagent states the reason for the shortage is manufacturing delay. • Hikma did not provide a reason for the shortage. • Ben Venue closed its plant in Bedford, Ohio in July 2014. • Virtus discontinued ketorolac in March 2019. • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac. • Sprix Nasal Spray is not affected by this shortage.

Estimated Resupply Dates • Alvogen has ketorolac 30 mg/mL 1 mL vials and 2 mL vials on back order and the company

cannot estimate a release date. • Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate

a release date. • Athenex has ketorolac 30 mg/mL 1 mL vials for intramuscular injection on allocation. • Fresenius Kabi has ketorolac 15 mg/mL 1 mL prefilled syringes on back order and the company

estimates a release date of mid- to late-November 2019. The 30 mg/mL 1 mL vials and 30 mg/mL 2 mL vials for intramuscular injection are on back order and the company estimates a release date of early-December 2019. The ketorolac 30 mg/mL 1 mL prefilled syringes are available with short expiry of < 3 months.

• Hikma has all ketorolac presentations on back order and the company estimates a release date of mid- to late-January 2020.

• Pfizer has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of November 2019. The 30 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2020. The 30 mg/mL 2 mL Carpuject syringes for intramuscular injection and 30 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of August 2020.


• Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Droperidol Injection November 11, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortage.

Estimated Resupply Dates • American Regent has droperidol 2.5 mg/mL 2 mL vials on back order and the company cannot

estimate a release date. • Pfizer has droperidol 2.5 mg/mL ampules on back order and the company estimates a release

date of March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=603 Cefotaxime Sodium Injection November 11, 2019 Reason for the Shortage

• Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no longer making the product.

• Baxter discontinued Claforan in late-2015. • Hikma is not currently marketing cefotaxime injection.

Estimated Resupply Dates • Apollo Pharmaceuticals is temporarily importing cefotaxime 1 gram and 2 gram vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=51 Buprenorphine Hydrochloride Injection November 11, 2019 Reason for the Shortage

• Pfizer has buprenorphine injection on shortage due to manufacturing delays. • Par had buprenorphine injection on shortage due to increased demand.

Estimated Resupply Dates • Pfizer has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes on back order and the company

estimates a release date of August 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=419 Asparaginase Erwinia chrysanthemi November 11, 2019 Reason for the Shortage

• Erwinaze supply disruption is due to ongoing manufacturing issues and capacity constraints at Porton Biopharma Limited, the sole manufacturer of Erwinaze. Erwinaze is distributed by Jazz Pharmaceuticals.

Estimated Resupply Dates • Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and

the company estimates a release date of late-November to early-December 2019.


• There is a new process for ordering Erwinaze. Additional information regarding the new ordering process is available at www.erwinazesupply.com.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=482 Tacrolimus Injection November 12, 2019 Reason for the Shortage

• Astellas did not provide a reason for the shortage. Estimated Resupply Dates

• Astellas has Prograf 5 mg/mL 1 mL ampules on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=588 Recombinant Zoster Vaccine (Shingrix) November 12, 2019 Reason for the Shortage

• GlaxoSmithKline has Shingrix on shortage due to high demand for the product. Estimated Resupply Dates

• GlaxoSmithKline has Shingrix on allocation with regular releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=427 Octreotide Injection November 12, 2019 Reason for the Shortage

• Fresenius Kabi had octreotide injection on back order due to increased demand. • Hikma did not provide a reason for the shortage. • Mylan Institutional refuses to provide availability updates. • Sagent has octreotide on shortage due to increased demand. • Sun Pharma is not currently marketing octreotide. • Teva did not provide a reason for the shortage. • Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018.

Estimated Resupply Dates • Hikma has octreotide 100 mcg/mL 1 mL vials and 500 mcg/mL 1 mL vials on back order and the

company estimates a release date of early-April 2020. • Sagent has octreotide 50 mcg/mL 1 mL vials, 100 mcg/mL 1 mL vials, and 1,000 mcg/mL 5 mL

vials on back order and the company estimates a release date in November 2019. There are short-dated 1,000 mcg/mL 5 mL vials available with an expiration date of February 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229 Methocarbamol Tablets November 12, 2019 Reason for the Shortage

• Bayshore states the shortage is due to increased demand. • Camber states the shortage is due to an API shortage. • Endo did not provide a reason for the shortage. • Hikma is not actively marketing methocarbamol tablets.


• Par discontinued methocarbamol tablets in July 2018. • Solco states the shortage is due to an API shortage. • Virtus discontinued methocarbamol tablets in June 2019.

Estimated Resupply Dates • Camber has all methocarbamol tablets available for contracted customers. All presentations are

on allocation for non-contracted customers. • Solco has all methocarbamol tablets on allocation. • Endo has Robaxin 750 mg tablets in 100 count on back order and the company cannot estimate

a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423 Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution November 12, 2019 Reason for the Shortage

• Altaire has recalled several medications due concerns over lack of sterility assurance. More information can be found at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-ocusoft.

Estimated Resupply Dates • Altaire has fluorescein/proparacaine 5 mL bottles on back order and the company cannot

estimate a release date. • OCuSOFT has Flucaine 5 mL bottles on back order and the company cannot estimate a release

date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=581 Busulfan Injection November 12, 2019 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Amneal has busulfan injection available. • Apotex launched busulfan injection in August 2019. • Armas Pharmaceuticals launched busulfan injection in mid-2019. • Athenex launched busulfan injection in March 2019. • Mylan Institutional has busulfan injectable available. • Sagent has busulfan injection available. • Teva has busulfan injection available. • Otsuka has Busulfex available.

Estimated Resupply Dates • Amneal has short-dated busulfan 6 mg/mL 10 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=509 Ranitidine Injection November 13, 2019 Reason for the Shortage

• Mylan has ranitidine injection available.


• Teligent has Zantac IV on shortage due to production delays. • Zydus has ranitidine injection on shortage because the product is undergoing additional testing

to ensure patient safety. Estimated Resupply Dates

• Zydus has ranitidine 25 mg/mL 2 mL, 6 mL, and 40 mL vials on back order and the company cannot estimate a release date.

• Teligent has all Zantac injection presentations on back order and the company estimates a release date of February 2020

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=426 Meropenem Injection November 13, 2019 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Pfizer has meropenem injection on shortage due to manufacturing delays. • Sagent discontinued meropenem injection. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • AuroMedics has meropenem 500 mg vials on intermittent back order and the company

estimates a release date of early-December 2019. • Pfizer has Merrem 500 mg vials (NDC 00310-0325-20) and 1 gram vials (NDC 00310-0321-30) on

back order and the company estimates a release date of March 2020. Pfizer has generic meropenem 500 mg (NDC 00409-3505-01) and 1 gram vials (NDC 00409-3506-01) on back order and the company estimates a release date of August 2020.

• Sandoz has all meropenem presentations on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=475 Hydroxyprogesterone Caproate Injection November 13, 2019 Reason for the Shortage

• AMAG has Makena vials on shortage due to manufacturing delay. • American Regent has hydroxyprogesterone injection available. • AuroMedics has hydroxyprogesterone injection available. • Mylan has hydroxyprogesterone injection available. • Prasco discontinued the 5 mL vials in mid-2019. Prasco has hydroxyprogesterone 1 mL vials

available. • Slayback Pharma has hydroxyprogesterone injection available.

Estimated Resupply Dates • AMAG has Makena 250 mg/mL 1 mL and 5 mL vials on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=501


Heparin Injection November 13, 2019 Reason for the Shortage

• Fresenius Kabi has put heparin on a protective allocation due to a potential shortage of raw ingredient. The letter describing this in detail is available at the following link: https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin.

• Hikma did not provide a reason for the shortage. • Mylan has heparin injection available. • Pfizer has heparin on shortage due to manufacturing delays. • Sagent has heparin on shortage due to manufacturing issues and increased demand.

Estimated Resupply Dates • Fresenius Kabi has short-dated heparin 5,000 unit/mL 1 mL prefilled syringes available with an

expiration date of <7 months. The 10,000 unit/mL 4 mL vials are on back order and the company cannot estimate a release date. All other presentations are on allocation.

• Hikma has 1,000 unit/mL 2 mL vials, 5,000 unit/mL 2 mL vials, and 10,000 unit/mL 2 mL vials on allocation.

• Pfizer has 5,000 unit/mL 1 mL Carpuject syringes available in limited supply. The 5,000 unit/mL 1 mL glass vials are on back order and the company estimates a release date of December 2019. The 5,000 unit/mL 10 mL vials (NDC 00409-2723-02) are on back order and the company estimates a release date of December 2019. The 5,000 unit/mL 10 mL glass vials (NDC 00069-0059-01) are on back order and the company estimates a release date of January 2020. The 10,000 unit/mL 0.5 mL Carpuject syringes are available in limited supply. The 1,000 unit/mL 1 mL vials are on back order and the company estimates a release date of November 2019.The 1,000 unit/mL 10 mL vials (NDC 00069-0058-01) are on back order and the company estimates a release date of November 2019.

• Sagent has heparin 1,000 unit/mL 1 mL, 10 mL, and 30 mL vials on allocation. The 1,000 unit/mL 2 mL vials are on back order with an estimated release date of November 2019. The 5,000 unit/mL 10 mL vials are on allocation. The 10,000 unit/mL 1 mL vials and 20,000 unit/mL 1 mL vials are on allocation. The 10,000 unit/mL 4 mL vials are on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353 Haloperidol Tablets November 13, 2019 Reason for the Shortage

• Mylan did not provide a reason for the shortage. • Sandoz has discontinued all haloperidol tablet presentations.

Estimated Resupply Dates • Mylan Institutional has haloperidol 0.5 mg tablets in 100 count unit-dose packs on back order

and the company estimates a release date of mid-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=459


Docusate Sodium Oral Liquid in Bulk Bottles November 13, 2019 Reason for the Shortage

• Akorn has Docu Liquid on shortage because they are waiting on raw ingredients. • Geri-Care had a contract manufacturer shut down. The company has discontinued Diocto syrup

and liquid. • Lannett did not provide a reason for the shortage. • Docusate sodium 10 mL unit dose cups are not affected.

Estimated Resupply Dates • Akorn has Docu Liquid in 473 mL bottles on back order and the company estimates a release

date of late-November 2019. • Geri-Care discontinued Diocto liquid in 473 mL bottles the company plans to relaunch the

product in the 2nd or 3rd quarter of 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=585 Dexrazoxane Injection November 13, 2019 Reason for the Shortage

• Cumberland Pharmaceuticals relaunched Totect in late-July 2017. • Fosun Pharma has dexrazoxane available. • Hikma has dexrazoxane available. • Mylan Institutional has dexrazoxane available. • Pfizer states manufacturing delay as the reason for the shortage

Estimated Resupply Dates • Pfizer has Zinecard 500 mg vials on back order and the company estimates a release date of

December 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=107 Ceftazidime Injection November 13, 2019 Reason for the Shortage

• Pfizer has Tazicef available. • Sagent has ceftazidime injection on shortage due to increased demand and manufacturing

delays. • BBraun had ceftazidime on allocation due to increased demand. • Teligent discontinued Fortaz 2 gram vials, 6 gram vials, and both 1 gram/50 mL and 2 gram/50

mL premixes in February 2018. They also discontinued the 1 gram and 2 gram Twistvials in April 2019. The Fortaz 500 mg and 1 gram vials are on back order due to manufacturing delays.

• WG Critical Care has ceftazidime available. Estimated Resupply Dates

• Pfizer has Tazicef 2 gram vials available in limited supply. • Teligent has ceftazidime 500 mg and 1 gram vials on back order and the company estimates a

release date of February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=63


Rabies Immune Globulin November 14, 2019 Reason for the Shortage

• Sanofi Pasteur has Imogam Rabies-HT on shortage due to manufacturing delays. Estimated Resupply Dates

• Sanofi Pasteur has Imogam Rabies-HT available with ordering restrictions. Access post-exposure information via link on the VACCINESHOPPE home page found at https://www.vaccineshoppe.com/. The company cannot estimate a release date for orders placed before the post-exposure ordering restrictions went into effect.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=591 Prednisolone Acetate 1% Ophthalmic Suspension November 14, 2019 Reason for the Shortage

• Allergan has Pred Forte available. • Greenstone did not provide a reason for the shortage. • Novartis discontinued Omnipred 1% in 2018. • Sandoz has prednisolone acetate ophthalmic suspension available.

Estimated Resupply Dates • Greenstone has prednisolone acetate 1% ophthalmic suspension in 15 mL bottles on back order

and the company estimates a release date in late-November 2019. The 5 mL and 10 mL bottles are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=536 Ondansetron Hydrochloride Injection November 14, 2019 Reason for the Shortage

• Apotex has ondansetron injection available. • Athenex had ondansetron injection on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • Heritage had ondansetron on shortage due to increased demand. Heritage discontinued

ondansetron 2 mg/mL 2 mL vials in 10 count in late-2018. • Hikma did not provide a reason for the shortage. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has ondansetron injection on shortage due to manufacturing delays. • Sagent has ondansetron injection available. • Novartis discontinued Zofran 20 mL vials in May 2018.

Estimated Resupply Dates • AuroMedics has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on intermittent back order and

the company is releasing supplies as they become available. • Fresenius Kabi has ondansetron 2 mg/mL 20 mL vials on back order and the company estimates

a release date of mid-December 2019. • Hikma has ondansetron 2 mg/mL 20 mL vials in 1 count and 10 count on back order and the

company cannot estimate a release date.


• Mylan Institutional has ondansetron 2 mg/mL 2 mL vials on intermittent back order and the company is releasing supplies as they become available.

• Pfizer has ondansetron 2 mg/mL 2 mL iSecure syringes on back order and the company estimates a release date of August 2020. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405 Midazolam Injection November 14, 2019 Reason for the Shortage

• Athenex did not provide a reason for the shortage. • Fresenius Kabi has midazolam injection on back order due to increased demand. • Hikma has midazolam injection available. • Pfizer has midazolam injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Athenex has midazolam 5 mg/mL 10 mL vials on back order and the company estimates a

release date of January 2020. • Fresenius Kabi has midazolam 1 mg/mL 10 mL vials and midazolam 5 mg/mL 5 mL vials on back

order and the company cannot estimate a release date. There are short-dated midazolam 5 mg/mL 1 mL syringes and 1 mL fill in 2 mL vials syringes with expiration dates of <6 months.

• Pfizer has midazolam 1 mg/mL 2 mL Carpuject syringes, 1 mg/mL 2 mL iSecure syringes, and 5 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of June 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=576 Methotrexate Injection November 14, 2019 Reason for the Shortage

• Accord has methotrexate injection on back order due to increased demand. • Fresenius Kabi has methotrexate injection available. • Mylan Institutional has methotrexate injection available. • Pfizer did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Hikma has methotrexate injection available.

Estimated Resupply Dates • Pfizer has methotrexate 25 mg/mL 2 mL vials on intermittent back order and the company

estimates the next release in November 2019. • Teva has methotrexate 25 mg/mL 40 mL vials on allocation. Please check with your wholesaler.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Lorazepam Injection November 14, 2019 Reason for the Shortage

• Bedford discontinued lorazepam injection in May, 2011. • Hikma has product on shortage due to manufacturing delays.


• Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer discontinued 4 mg/mL 10 mL vials in December 2017.

• Akorn did not provide a reason for the shortage. • Amphastar has product available.

Estimated Resupply Dates • Akorn has lorazepam 2 mg/mL 1 mL vials on back order and the company cannot estimate a

release date. • Hikma has lorazepam 2 mg/mL 1 mL vials on back order and the company estimates a release

date of late-November 2019. • Pfizer has lorazepam 4 mg/mL 1 mL Carpuject syringes on back order and the company

estimates a release date of January 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Leucovorin Calcium Injection November 14, 2019 Reason for the Shortage

• Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand. • Hikma did not provide a reason for the current shortage. • Mylan did not provide a reason for the current shortage. • Sagent has leucovorin on shortage due to manufacturing delays. • Teva has leucovorin available.

Estimated Resupply Dates • Fresenius Kabi has leucovorin 200 mg and 500 mg vials on back order and the company

estimates a release date of early-December 2019 for the 200 mg vials and mid-November 2019 for the 500 mg vials. Leucovorin 10 mg/mL 10 mL vials are on back order and the company estimates a release date of 4th quarter 2019.

• Hikma has leucovorin 50 mg, 100 mg, and 200 mg vials on back order and the company estimates a release date of mid-December 2019. The 350 mg vials are on allocation.

• Mylan has leucovorin 200 mg vials on back order and the company estimates a release date of late-November 2019.

• Sagent has leucovorin 50 mg vials on back order and the company estimates a release date of March 2020. The 100 mg, 200 mg, 350 mg, and 500 mg vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Fentanyl Citrate Injection November 14, 2019 Reason for the Shortage

• Akorn has fentanyl injection available. They are not currently marketing 25 count fentanyl ampules.

• Hikma has fentanyl injection on shortage due to supply and demand issues. They are not currently marketing fentanyl ampules, just vials.

• Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were discontinued in September 2017.

• Fresenius Kabi did not provide a reason for the shortage. Estimated Resupply Dates


• Fresenius Kabi has fentanyl 50 mcg/mL 50 mL vials on back order and the company estimates a release date of mid- to late-November 2019.

• Pfizer has fentanyl 50 mcg/mL 20 mL and 50 mL vials on back order and the company estimates a release date of November 2019. The 50 mcg/mL 2 mL and 10 mL vials are available in limited supply. The 50 mcg/mL 2 mL ampules are on back order and the company estimates a release date of November 2019. The 2 mL Carpuject syringes are on back order and the company estimates a release date of August 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Enoxaparin Sodium Injection November 14, 2019 Reason for the Shortage

• Amphastar has enoxaparin available. • Apotex launched enoxaparin in early-2019. • Fresenius Kabi did not provide a reason for the shortage. Fresenius Kabi updated NDC numbers

of the 80 mg and 100 mg prefilled syringes in October 2019. • Sandoz discontinued enoxaparin presentations in mid-2018 due to a supplier issue. • Sanofi-Aventis did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Winthrop did not provide a reason for the shortage.

Estimated Resupply Dates • Fresenius Kabi has enoxaparin 100 mg prefilled syringes on back order and the company

estimates a release date in mid-November 2019. • Sanofi-Aventis has a limited supply of Lovenox 40 mg and 100 mg prefilled syringes. The 60 mg

and 150 mg Lovenox prefilled syringes are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=466 Dexamethasone Sodium Phosphate Injection November 14, 2019 Reason for the Shortage

• American Regent is not marketing dexamethasone sodium phosphate injection at this time. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has dexamethasone sodium phosphate presentations available. • Mylan Institutional has dexamethasone injection available. • Hikma has dexamethasone injection on shortage due to increased demand. • Somerset Therapeutics has 10 mg/mL 1 mL vials available.

Estimated Resupply Date • AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5 mL, and 30 mL vials on

intermittent back order and the company is releasing product as it becomes available. • Hikma has dexamethasone sodium phosphate 4 mg/mL 5 mL vials on back order and the

company estimates a release date of early-December 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Daptomycin Injection


November 14, 2019 Reason for the Shortage

• Fresenius Kabi has daptomycin available. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has daptomycin on shortage due to manufacturing delays. • Teva has daptomycin available. • Sagent had daptomycin on shortage due to manufacturing delays. • Merck has Cubicin and Cubicin RF available. • Xellia Pharmaceuticals has daptomycin available

Estimated Resupply Dates • Mylan Institutional has daptomycin 500 mg vials on intermittent back order and the company is

releasing supplies as they become available. • Pfizer has daptomycin 500 mg vials on back order and the company estimates a release date of

March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=467 Cefazolin Injection November 14, 2019 Reason for the Shortage

• Apotex has discontinued all presentations except cefazolin 1 gram vials. • Baxter has cefazolin on shortage due to increased demand. • BBraun has cefazolin on shortage due to manufacturing delays. • Fresenius Kabi has cefazolin on shortage due to increased demand. They are not manufacturing

the 20 gram vials at this time to focus on the other sizes. • Hikma did not provide a reason for the shortage. • Pfizer states the reason for the shortage is manufacturing delay. • Sagent states the reason for the shortage is manufacturing delays and increased demand. • Samson Medical Technologies has cefazolin injection available. • Sandoz did not provide a reason for the shortage. • WG Critical Care did not provide a reason for the shortage.

Estimated Resupply Dates • Baxter has cefazolin 2 gram/100 mL premixed bags on allocation. • BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation. • Fresenius Kabi has cefazolin 1 gram and 10 gram vials on back order. The company estimates a

release date of mid-February 2020 for the 10 gram vials and cannot estimate a release date for the 1 gram vials.

• Hikma has cefazolin 10 gram vials on allocation. • Pfizer has cefazolin 1 gram vials and 10 gram vials on back order and the company estimates a

release date of March 2021. • Sagent has cefazolin 500 mg, 1 gram, and 10 gram vials on allocation. • Sandoz has cefazolin 10 gram vials on back order and the company cannot estimate a release

date. • WG Critical Care has cefazolin 10 gram vials on allocation and is shipping product weekly.



Temazepam Capsules November 15, 2019 Reason for the Shortage

• Ascend did not provide a reason for the shortage. • Major had temazepam on shortage due to manufacturing delays. • Mylan did not provide a reason for the shortage. • Sun Pharma discontinued temazepam capsules in 2019. • Teva has temazepam capsules available. • Mallinckrodt has Restoril capsules available. • Mylan Institutional discontinued temazepam capsules in unit-dose packaging.

Estimated Resupply Dates • Ascend has temazepam 15 mg and 30 mg capsules in 500 count bottles on intermittent back

order and the company is releasing supplies as they become available. • Mylan has all presentations of temazepam capsules on back order and the company estimates a

release date of January 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=503 Sterile Water for Injection – Small Volume Vials November 15, 2019 Reason for the Shortage

• American Regent has sterile water for injection available. • Fresenius Kabi had sterile water on shortage due to increased demand. • Hikma has sterile water for injection available. • Pfizer had sterile water for injection in vials on shortage due to increased demand.

Estimated Resupply Dates • Fresenius Kabi has sterile water for injection 100 mL vials on back order and the company

estimates a release date of late-November 2019. The 5 mL vials are on back order and the company estimates a release date of mid-December 2019.

• Hikma has short-dated sterile water for injection 10 mL vials available with an expiration date of https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375 Sodium Bicarbonate Injection November 15, 2019 Reason for the Shortage

• Amphastar has sodium bicarbonate injection on shortage due to increased demand. • Athenex has sodium bicarbonate available. • Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays. • Fresenius Kabi had sodium bicarbonate injection temporarily available, but have run out of

stock, there is more in production at this time. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293


Sodium Acetate Injection November 15, 2019 Reason for the Shortage

• American Regent is not currently marketing sodium acetate injection. • Fresenius Kabi has sodium acetate injection on back order due to increased demand. • Pfizer has sodium acetate injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has sodium acetate 2 mEq/mL 20 mL, 50 mL, and 100 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=317 Ropivacaine Injection November 15, 2019 Reason for the Shortage

• Akorn had ropivacaine on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays. • Pfizer had ropivacaine on shortage due to manufacturing delays. • Sagent has ropivacaine premixed bags available. • Somerset Therapeutics has ropivacaine 5 mg/mL 30 mL vials available.

Estimated Resupply Dates • AuroMedics has ropivacaine 10 mg/mL 10 mL and 20 mL vials and 2 mg/mL 100 mL bottles on

intermittent back order and the company is releasing product as it becomes available. • Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company

cannot estimate a release date. The 2 mg/mL 10 mL and 20 mL Steripak ampules are on back order and the company estimates a release date of early-February 2020 for the 10 mL ampules and early-December 2019 for the 20 mL ampules. The 2 mg/mL 200 mL bottles are on back order and the company estimates a release date of late-January 2020. The 5 mg/mL 200 mL bottles are on back order and the company estimates a release date of early- to mid-December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Morphine Injection November 15, 2019 Reason for the Shortage

• Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.

• Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.

• Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes.

• Hikma did not provide a reason for the shortage. • Piramal Critical Care has Mitigo 10 mg/mL 20 mL and 25 mg/mL 20 mL vials available.



• Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.

• Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.

• Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes.

• Hikma did not provide a reason for the shortage. • Piramal Critical Care has Mitigo 10 mg/mL 20 mL and 25 mg/mL 20 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Metoprolol Injection November 15, 2019 Reason for the Shortage

• Alvogen has metoprolol injection available. • American Regent is not currently marketing metoprolol injection. • Athenex has metoprolol injection available. • Baxter has metoprolol injection available. • Fosun Pharma has metoprolol injection available. • Fresenius Kabi had metoprolol injection on shortage due to increased demand. • Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol

injection in March 2018. • Pfizer has metoprolol injection on shortage due to manufacturing delays. • Hikma did not provide a reason for the shortage.

Estimated Resupply Dates • Hikma has metoprolol 1 mg/mL 5 mL vials on back order and the company estimates a release

date of late-January 2020. The 10 mL vials are on available. • Pfizer has metoprolol 1 mg/mL 5 mL Carpuject syringes on back order and the company

estimates a release date of August 2020. The 1 mg/mL 5 mL ampules are on back order and the company estimates a release date of August 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=363 Mepivacaine Injection November 15, 2019 Reason for the Shortage

• Fresenius Kabi has Polocaine available. • Pfizer states the reason for the shortage is manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has 1.5% Polocaine 30 mL preservative-free vials on back order and the company

estimates a release date of early- to mid-December 2019. • Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose

vials, 1% Carbocaine 30 mL preservative-free vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of March 2020. The 1% Carbocaine 50 mL multiple-dose vials are on back order and the company estimates a release date of December 2019.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Magnesium Sulfate Injection November 15, 2019 Reason for the Shortage

• American Regent is not currently marketing magnesium sulfate which has been unavailable since late 2012.

• Fresenius Kabi had magnesium sulfate injection on shortage due to increased demand for the product.

• Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. • X-Gen discontinued magnesium sulfate in April 2018. • Exela launched magnesium sulfate vials in May 2018. • WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the

product. Estimated Resupply Dates

• Fresenius Kabi has magnesium sulfate 40 mg/mL 500 mL premixed bags on back order and the company estimates a release date of mid-February 2020.

• Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of March 2020. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of December 2020. The 40 mg/mL 500 mL and 1,000 mL premixed bags are on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Lidocaine with Epinephrine Injection November 15, 2019 Reason for the Shortage

• Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

• Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 1% Xylocaine with epinephrine (1:200,000) 10 mL vials on back order and the company estimates release dates of late-November 2019. The 1% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates release dates of mid- to late-November 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of mid- to late-November 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates release dates of late-November 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates release dates of late-November 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of mid- to late-November 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of mid-December 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of mid- to


late-November 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

• Pfizer has 1% lidocaine with epinephrine (1:100,000) 30 mL vials available in limited supply. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are available in limited supply. The 2% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of November 2019. The 2% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of December 2019. The 2% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of November 2019. The 2% lidocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of November 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Lidocaine Injection November 15, 2019 Reason for the Shortage

• Amphastar had lidocaine 2% emergency syringes available. • AuroMedics introduced lidocaine injection in February 2014. • Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of

raw ingredients. • Pfizer has lidocaine presentations on shortage due to manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has 1% Xylocaine-MPF 30 mL vial sterile packs on back order and the company

cannot estimate a release date. The 1% Xylocaine-MPF 10 mL vial sterile packs on back order and the company estimates a release date of late-December 2019 to early-January 2020. The 1% Xylocaine 50 mL vial sterile packs on back order and the company estimates a release date of mid-December 2019. The 1.5% Xylocaine-MPF 20 mL ampules are on back order and the company estimates a release date of early- to mid-December 2019. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of early- to mid-December 2019. Check wholesalers for inventory.

• Hikma has 1% lidocaine 5 mL vials on back order and the company estimates a release date of mid-November 2019. The 2% lidocaine 5 mL vials are on allocation.

• Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a release date of March 2020. The 1% lidocaine 30 mL preservative-free vials available in limited supply. The 1% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of April 2020. The 1% lidocaine 5 mL LifeShield syringes are on back order and the company estimates a release date of December 2019. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the company estimates a release date of February 2020. The 2% lidocaine 5 mL vials are available in limited supply. The 2% lidocaine 5 mL LifeShield syringes are on back order and the company estimates a release date of December 2019. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of March 2020.



Epinephrine Auto-Injectors November 15, 2019 Reason for the Shortage

• Amneal has discontinued Adrenaclick. Amneal acquired Impax in 2018. • Mylan refused to provide availability information. • Sandoz launched Symjepi in January 2019 and product is available. • Teva has FDA approval for generic epinephrine.

Estimated Resupply Dates • Amneal has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420 Enalaprilat Injection November 15, 2019 Reason for the Shortage

• Hikma has enalaprilat injection on shortage due to increased demand. • Pfizer has enalaprilat injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Hikma has enalaprilat 1.25 mg/mL 1 mL on allocation. The 2 mL vials are on back order and the

company estimates a release date of mid-December 2019. • Pfizer has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on back order and the company estimates

a release date of March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=488 Bupivacaine with Epinephrine Injection November 15, 2019 Reason for the Shortage

• Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

• Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the company estimates a release date of early- to mid-December 2019. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-December 2019. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-November 2019. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of late-November 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-November 2019. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of mid-December 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date.

• Pfizer has 0.25% bupivacaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of February 2020. The 0.25% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of March 2020. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of May 2020. The 0.5% bupivacaine with


epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of March 2020. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of March 2020.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of March 2020.

• Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of December 2019. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are available in limited supply. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of November 2019. The 0.5% Marcaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Anagrelide Hydrochloride Capsules November 15, 2019 Reason for the Shortage

• Shire (Takeda) did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Torrent is working on relaunching anagrelide 0.5 mg capsules.

Estimated Resupply Dates • Shire (Takeda) has Agrylin 0.5 mg capsules available in limited supply. Shire estimates Agrylin

will return to full supply in January 2020. • Teva has anagrelide 0.5 mg and 1 mg capsules on back order and the company estimates a

release date in early- to mid-January 2020. • Torrent has anagrelide 0.5 mg capsules unavailable and the company cannot estimate a

relaunch date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=610 Ampicillin Sodium and Sulbactam Sodium Injection November 15, 2019 Reason for the Shortage

• AuroMedics has ampicillin sulbactam vials on back order due to increased demand and manufacturing delays.

• Fresenius Kabi is not currently marketing ampicillin sulbactam injection. • Meitheal Pharmaceuticals has ampicillin sulbactam available. • Mylan Institutional refuses to provide availability information • Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-

Vantage vials. • Piramal Critical Care has ampicillin sulbactam available. • Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased

demand. • Sandoz discontinued ampicillin sulbactam.


• WG Critical Care states the shortage is due to increased demand. Estimated Resupply Dates

• AuroMedics has ampicillin sulbactam 3 gram and 15 gram vials on intermittent back order and the company is releasing product as it becomes available. The 1.5 gram vials are on long-term back order and the company cannot estimate a release date.

• Hikma has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company estimates a release date of mid- to late-November 2019.

• Pfizer has Unasyn 1.5 gram, 3 gram, and 15 gram bulk vials on back order and the company estimates a release date of December 2019. The 1.5 gram and 3 gram ADD-Vantage vials are on back order and the company estimates a release date of February 2020.

• Sagent has ampicillin sulbactam 1.5 gram vials on allocation. The 3 gram, and 15 gram bulk vials are on back order and the company estimates a release date of November 2019 for the 3 gram vials and January 2020 for the 15 gram vials.

• WG Critical Care has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram bulk vials on back order and the company estimates a release date of January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Aminophylline Injection November 15, 2019 Reason for the Shortage

• Pfizer has aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has aminophylline 25 mg/mL 20 mL vials on back order and the company estimates a release date of November 2019. There are short-dated 25 mg/mL 10 mL vials available with an expiration date of April 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407 Acyclovir Injection November 15, 2019 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has acyclovir injection on shortage due to increased demand.

Estimated Resupply Dates • AuroMedics has acyclovir 50 mg/mL 10 mL and 20 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Fresenius Kabi has acyclovir 50 mg/mL 10 mL and 20 mL vials on back order and the company

estimates a release date of late-November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=590 23.4% Sodium Chloride Injection November 15, 2019 Reason for the Shortage

• Fresenius Kabi had 23.4% sodium chloride injection on shortage due to increased demand. • Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.



• Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 Thiamine Injection November 18, 2019 Reason for the Shortage

• Fresenius Kabi had thiamine injection on shortage due to short manufacturing delay. • Mylan Institutional has thiamine injection available.

Estimated Resupply Dates • Fresenius Kabi has thiamine 100 mg/mL 2 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=502 Piperacillin and Tazobactam Injection Injection November 18, 2019 Reason for the Shortage

• Apollo Pharmaceuticals has piperacillin/tazobactam injection available. • Apotex did not provide a reason for the shortage. • Athenex has piperacillin/tazobactam injection available. • AuroMedics has piperacillin/tazobactam injection available. • Baxter did not provide a reason for the shortage. • Fresenius Kabi has piperacillin/tazobactam injection available. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays. • Sagent has piperacillin/tazobactam injection on shortage due to increased demand. • Sandoz has piperacillin/tazobactam injection available. • WG Critical Care did not provide a reason for the shortage. • Wockhardt did not provide a reason for the shortage • X-Gen did not provide a reason for the shortage.

Estimated Resupply Dates • Apotex has piperacillin/tazobactam 3.375 gram and 4.5 gram vials on allocation. The 2.25 gram

vials are on back order and the company estimates a release date of mid-December 2019. The 40.5 gram bulk vials on back order and the company cannot estimate a release date.

• Baxter has Zosyn 4.5 gram frozen premixed bags on back order and the company estimates a release date of November 2019.

• Pfizer has Zosyn 2.25 gram vials, 3.375 gram vials, 4.5 gram vials, and 40.5 gram vials on back order and the company estimates a release date of March 2020.

• Sagent has piperacillin/tazobactam 2.25 gram vials on back order and the company estimates a release date of November 2019. The 4.5 gram vials on back order and the company estimates a release date of December 2019.

• Wockhardt has piperacillin/tazobactam 2.25 gram vials on back order and the company estimates a release date of early-December 2019. The 3.375 gram vials are on back order and the company estimates a release date of late-October 2019. The 4.5 gram and 40.5 gram vials are on allocation.


• WG Critical care has the 2.25 gram and 40.5 gram vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=158 PCA Sterile Empty Vials and Injectors November 18, 2019 Reason for the Shortage

• ICU Medical had LifeCare PCA sterile empty vials and injectors on shortage due to manufacturing delays.

Estimated Resupply Dates • ICU Medical has LifeCare PCA sterile empty vials and injectors available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=493 Oxytocin Injection November 18, 2019 Reason for the Shortage

• Fresenius Kabi has oxytocin injection on shortage due to manufacturing delays. • Par has Pitocin available.

Estimated Resupply Dates • Fresenius Kabi has oxytocin 1 mL, 10 mL, and 30 mL vials on back order and the company

estimates a release date of mid- to late-November 2019 for the 1 mL vials, early-December 2019 for the 10 mL vials, and late-November 2019 for the 30 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=608 Dexmedetomidine Hydrochloride 100mcg/mL Vials for Injection November 18, 2019 Reason for the Shortage

• Accord has dexmedetomidine vials available. • Akorn is no longer manufacturing dexmedetomidine vials. • Athenex has dexmedetomidine vials available. • AuroMedics has dexmedetomidine vials available. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. • Mylan did not provide a reason for the shortage. • Par has dexmedetomidine vials available. • Pfizer has dexmedetomidine vials available. • Sandoz has dexmedetomidine vials available. • Sun Pharma is no longer manufacturing dexmedetomidine. • Teva discontinued dexmedetomidine vials in July 2019. • WG Critical Care has dexmedetomidine vials on back order due to manufacturing delays.

Estimated Resupply Dates • Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates

a release date of mid-December 2019. • Mylan Institutional has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the

company cannot estimate a release date.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=491 Cefepime Injection November 18, 2019 Reason for the Shortage

• Apotex has cefepime injection available. • Baxter has cefepime on allocation due to increased demand. • BBraun has cefepime on shortage due to manufacturing delays. • Fresenius Kabi has cefepime injection available. • Meitheal Pharmaceuticals has cefepime injection available • Pfizer has Maxipime on shortage due to manufacturing delays. • Piramal Critical Care has cefepime powder for solution for injection available. • Sagent has cefepime 1gram vials available. The 2 gram vials are on allocation due to increased

demand. • Samson Medical Technologies has cefepime injection available. • Sandoz discontinued cefepime injection in early-2016. • WG Critical Care has cefepime injection available.

Estimated Resupply Dates • BBraun has cefepime 1 gram and 2 gram premixed bags on allocation. • Pfizer has Maxipime 1 gram and 2 gram vials and 1 gram and 2 gram ADD-Vantage vials on back

order and the company estimates a release date of March 2021. • Sagent has cefepime 1 gram vials on allocation and the company estimates a release date of

November 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59 Carisoprodol Tablets November 18, 2019 Reason for the Shortage

• Cadista discontinued carisoprodol tablets. • Endo Pharmaceuticals discontinued carisoprodol tablets. • Mylan has Soma tablets available. • Rising discontinued carisoprodol tablets. • Sciegen has carisoprodol tablets available. • Teva did not provide a reason for the shortage.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=558 Carbidopa and Levodopa Extended-Release Tablets November 18, 2019 Reason for the Shortage

• Accord has discontinued carbidopa and levodopa 25 mg/100 mg extended-release tablets. The 50 mg/200 mg tablets are on shortage due to problems obtaining active ingredient.

• Sun Pharma had carbidopa and levodopa extended-release tablets on shortage due to increased demand.


• Merck will be discontinuing Sinemet CR 50 mg/200 mg tablets around November 2019. The 25 mg/100 mg tablets will be discontinued around February 2020.

• Mylan did not provide a reason for the shortage. Estimated Resupply Dates

• Mylan has carbidopa and levodopa 25 mg/100 mg extended-release tablets in 100 count unit-dose packs on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=349 Buspirone Tablets November 18, 2019 Reason for the Shortage

• Accord did not provide a reason for the shortage. • Mylan did not provide a reason for the shortage. • Par has buspirone tablets available. • Teva has buspirone tablets available. • Zydus has buspirone tablets available.

Estimated Resupply Dates • Accord has all buspirone presentations on allocation. • Mylan has buspirone 15 mg tablets in 180 count and 500 count on back order and the company

estimates a release date of November 2019. • Apnar has buspirone 15 mg tablets in 60 count bottles on back order and the company

estimates a release date of mid-2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=465 BCG Live Intravesical November 18, 2019 Reason for the Shortage

• Because of increased global demand, and as the only source of BCG Live (Intravesical) in the United States and many other countries, Merck anticipates supply constraints for Tice BCG in 2019. To minimize disruption to patient care and address the current imbalance between supply and increased global demand, Tice BCG will be under allocation when demand exceeds production plans and available inventory.

Estimated Resupply Dates • Merck has Tice BCG on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=519 Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment November 19, 2019 Reason for the Shortage

• Allergan did not provide a reason for the shortage. They are the sole suppliers of sulfacetamide sodium and prednisolone acetate ophthalmic ointment.

Estimated Resupply Dates • Allergan has Blephamide ophthalmic ointment on long-term back order and the company

cannot estimate a release date.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=611 Pantoprazole Injection November 19, 2019 Reason for the Shortage

• AuroMedics has pantoprazole injection on shortage due to increased demand. • Hikma did not provide a reason for the shortage. • Pfizer has Protonix injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Hikma has pantoprazole 40 mg vials on allocation. • Pfizer has Protonix 25 mg vials in 25 count and 40 mg vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=550 Ketamine Injection November 19, 2019 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Mylan Institutional has ketamine available. • Par had Ketalar on shortage due to increased demand. • Pfizer has ketamine on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has ketamine 50 mg/mL 10 mL vials on back order and the company estimates a release

date of January 2020. The 100 mg/mL 5 mL vials are on back order and the company estimates a release date of December 2019.


*Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

Documents

Drug Information Update - PerformRx · As a precautionary measure, Sanofi on Friday, October 18, initiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States