Drug Information Update...Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 m g Tablets, Lot # 331771 (expiration

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Drug Information Update February 2020

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

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

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

STUDIES AND RECENT TOPICS ............................................................... 11

RECALLS ................................................................................................ 15

CURRENT DRUG SHORTAGES ................................................................ 31


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM

GENERIC MANUFACTURER BRAND NAME

CALCIPOTRIENE 0.005 % FOAM AYURAX SORILUX

HYDROCODONE BITARTRATE 20 MG CAP ER 12H ALVOGEN INC ZOHYDRO ER

CALCIPOTRIENE/BETAMETHASONE

0.005 %-0.064 % SUSPENSION PRASCO LABS TACLONEX

INDOMETHACIN, SUBMICRONIZED

20 MG CAPSULE AYURAX TIVORBEX

KETOROLAC TROMETHAMINE 15.75 MG/SPRAY PRASCO LABS SPRIX


NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES ANTIPSYCHOTIC

/ATYPICAL, DOPAMINE, SEROTONIN ANTAGNST

CAPLYTA LUMATEPERONE TOSYLATE 42 MG CAPSULE NEW ENTITY

INSULIN-LIKE GROWTH FACTOR

RECEPTOR (IGF-R) INHIB

TEPEZZA TEPROTUMUMAB-TRBW

500 MG VIAL, IV SOLUTION NEW ENTITY

GLUCOCORTICOIDS, ORALLY

INHALED ASMANEX HFA MOMETASONE

FUROATE 50 MCG AEROSOL

INHALATION NEW

STRENGTH

BETA-ADRENERGIC

AND GLUCOCORTICOI

D COMBO, INHALED

DULERA

MOMETASONE/ FORMOTEROL

50 MCG-5 MCG AEROSOL INHALATION

NEW STRENGTH

ANTIHYPERGLYCEMIC,

BIGUANIDE TYPE RIOMET ER METFORMIN HCL 500 MG/5 ML ORAL

SUSPENSION NEW DOSAGE

FORM

ANTINEOPLASTIC –

PROTEIN,METHYLTRA-NSFERASE

INHIBIT

TAZVERIK TAZEMETOSTAT HYDROBROMIDE 200 MG TABLET NEW ENTITY

ANTI-CD20 (B LYMPHOCYTE) MONOCLONAL

ANTIBODY

RUXIENCE RITUXIMAB-PVVR 10 MG/ML IV CONCENTRATE

BIOSIMILAR TO RITUXAN

(RITUXIMAB)

ANTIMIGRAINE PREPARATIONS REYVOW LASMIDITAN

SUCCINATE 50 MG, 100 MG TABLET NEW ENTITY

OPIOID ANALGESICS TRAMADOL HCL TRAMADOL HCL 100 MG TABLET NEW

STRENGTH


DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

TOPICAL ANTI-INFLAMMATORY

STEROIDAL SILA III TRIAMCINOLONE/

GAUZE/SILICONE 0.1%-4"X4" TOPICAL KIT RX + OTC

ALLERGENIC EXTRACTS,

THERAPEUTIC

PALFORZIA

PEANUT ALLERGEN POWDER-DNFP

0.5 MG/1 MG/1.5 MG/3 MG/6 MG

CAP SPRINK, INITIAL DOSE

NEW ENTITY


THERAPEUTIC

PALFORZIA


3 MG (LEVEL 1), 6 MG (LEVEL 2), 12 MG (LEVEL 3),

20 MG (LEVEL 4), 40 MG (LEVEL 5), 80 MG (LEVEL 6), 120 MG (LEVEL 7), 160 MG (LEVEL 8), 200 MG (LEVEL

9), 240 MG (LEVEL 10) CAP SPRINK

NEW ENTITY


THERAPEUTIC

PALFORZIA


300 MG (LEVEL 11) POWDER PACK

NEW ENTITY

CEPHALOSPORIN ANTIBIOTICS - SIDEROPHORE

FETROJA CEFIDEROCOL SULFATE TOSYLATE 1 G VIAL NEW ENTITY


NEW INDICATIONS (EXISTING DRUGS) OZEMPIC January 16, 2020 Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.1 Additional details were added to the Rybelsus® (semaglutide) tablets 7 mg or 14 mg Prescribing Information about the primary analysis for PIONEER 6. Source: Neurelis, Inc. KEYTRUDA January 23, 2020 Merck today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Source: Novo Nordisk DIFICID January 27, 2020 Merck today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older. Source: Merck


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles [Posted January 10, 2020] Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200110005522/en/External Link Disclaimer Risk Statement: Use of Lamotrigine 100 mg Tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure. There is potential with chronic exposure to Enalapril Maleate to impact users particularly if they are small children or pregnant women. Enalapril Maleate is also associated with risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021). Taro has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall. Taro will continue to actively monitor for any and all adverse event reports that may be received, in compliance with FDA regulatory requirements. Lamotrigine 100 mg Tablets are indicated for Epilepsy and Bipolar disorder. This product is packaged in white plastic bottles with screw cap closure, and each bottle contains 100 tablets. Each bottle is labeled to indicate the name of the product, Lamotrigine Tablets USP, 100 mg, the NDC #51672-4131-1 (see image of container label below), the lot number 331771 and expiration date of June 2021. Lamotrigine 100 mg Tablets, Lot # 331771 were distributed to wholesale distributors in the US market between August 23 and August 30, 2019. These wholesale customers may have further distributed Lot # 331771 to retail pharmacies for prescription dispensing to patients who were prescribed 100 mg Lamotrigine Tablets. Taro is notifying its distributors and customers by Phone, E-mail, and Letters via US Mail and is arranging for return of any containers or quantities of Lamotrigine 100 mg Tablets, Lot # 331771 (exp. June 2021). Consumers that have any quantities of Lamotrigine 100 mg Tablets, Lot # 331771 being recalled should stop using this product and return it to the pharmacy that dispensed it. Retailers, pharmacies and distributors should stop distributing or dispensing this product and return it to Taro. Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at [email protected], Monday through Friday between 7:00 AM and 7:00 PM US Central Time.


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.

• 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) Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer [Posted January 14, 2020] ISSUE: The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review. BACKGROUND: Lorcaserin is a prescription medicine approved by FDA in 2012 for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weight-related medical problems. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR). RECOMMENDATION: Health care professionals should consider if the benefits of taking lorcaserin are likely to exceed the potential risks when deciding whether to prescribe or continue patients on lorcaserin. Patients currently taking lorcaserin should talk to their health care professionals about the potential increased risk of cancer with use of lorcaserin. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online. • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to

the address on form or submit by fax to 1-800-FDA-0178 Source: U.S. Food and Drug Administration (FDA)


FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products within Expiry Due to A Lack of Assurance of Sterility [Posted January 16, 2020] FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines. Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening. To date, FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical has not received any reports of adverse events related to this recall and is recalling all sterile products out of an abundance of caution and to promote patient safety, which is AXIA pharmaceutical’s highest priority. For a full listing of the products, including lot numbers and expiration dates, being recalled, please follow this link: http://www.axiapharma.net/recalls.htmlExternal Link Disclaimer. Sterile drug product was distributed nationwide to consumers. FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is notifying its customers by letter and direct outreach. FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is arranging for the return of all recalled products. Customers that have any recalled products should stop using and return to FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical. Consumers with questions regarding this recall can contact FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Erdwin Orellana by phone number: (877-685-8222Call: 877-685-8222) or e-mail address [email protected], Monday through Friday: 8:00 AM to 4:00 PM PST. 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.

• Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088Call: 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-0178Call: 1-800-FDA-0178

Source: U.S. Food and Drug Administration (FDA) Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems [Posted January 28, 2020]


ISSUE: FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed and treated quickly. BACKGROUND: Clozapine affects how the intestines (bowels) function in the majority of patients. It produces effects ranging from constipation (trouble having a bowel movement), which is a common occurrence, to serious but uncommon bowel problems, including complete blockage of the bowel. RECOMMENDATION: Patients should contact your health care professional if:

• their bowel movements are less frequent than normal. • they do not have a bowel movement at least three times a week. • they have hard or dry stools. • they have difficulty passing gas.

Patients should contact your health care professional right away if you have symptoms which can be associated with serious bowel problems such as:

• nausea • vomiting • bloating or belly swelling, or belly pain.

Health care professionals should:

• Evaluate bowel function before starting a patient on clozapine. • Avoid co-prescribing clozapine with other anticholinergic medicines that can cause

gastrointestinal hypomotility. • Advise patients frequently of the significant risk of constipation and life-threatening bowel

issues and the need to stay hydrated to prevent constipation. • Question patients about the frequency and quality of their bowel movements throughout

treatment. • Advise patients to contact a health care professional right away if they have difficulty having a

bowel movement or passing stools, do not have a bowel movement at least three times a week or less than their normal frequency, or are unable to pass gas.

• Monitor patients for symptoms of potential complications associated with gastrointestinal hypomotility such as nausea, abdominal distension or pain, and vomiting.

• Consider prophylactic laxative treatment when starting clozapine in patients with a history of constipation or bowel obstruction.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online


• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form or submit by fax to 1-800-FDA-0178

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


STUDIES AND RECENT TOPICS

Top Pharmacy Regulations for 2020: What Pharmacists Should Know

January 3, 2020

Pharmacists have an important responsibility not only to keep up with new drug approvals but also to stay abreast of the latest pharmacy regulations affecting the profession. The Oath of a Pharmacist states: “I will accept the lifelong obligation to improve my professional knowledge and competence.” Pharmacists can stay up to date by participating in continuing education (CE) programs, through various resources, such as professional organizations, and registering for email alerts with the Drug Enforcement Administration (DEA) and FDA.

Source: managedhealthcareexecutive.com

Phlegm-Busting Drug Shows Promise in Parkinson's

January 13, 2020

Ambroxol, a drug used in cough syrup to break up phlegm, may be worthy of further study as a neuroprotective compound in Parkinson's disease, AiM-PD trial results suggested.

Source: medpagetoday.com

FDA approval may not be as rigorous as it once was

January 14, 2020

Changes in U.S. Food and Drug Administration (FDA) procedures meant to speed approvals for medications may have resulted in less exacting standards, a new analysis suggests.

Congressional acts that changed the way the FDA evaluates drugs have led to less rigorous evaluations, with drug approvals being based on fewer and/or earlier-stage clinical trials that may not be randomized, controlled, blinded or based on traditional measures of efficacy, experts noted in the article published in JAMA..

Source: reuters.com

Neurologist Copes with Alzheimer's; Stem Cells vs Biologics in MS

January 14, 2020

In the wake of recent New York Times articles, a neurologist with early Alzheimer's and others wrote letters to the editor about coping with the disease.

WHO formally retracted its two main opioid guidelines after a review indicated the guidance -- which a U.S. congressional report described as "marketing materials for Purdue" -- may have been influenced by drug companies.



Simple Tweak to Hospital Computer Program Cuts Opioid Prescriptions

January 21, 2020

Could a simple computer hack help make a dent in the opioid epidemic?

New research suggests that the number of painkillers prescribed to patients can be reduced just by lowering default computer settings that display a preset number of pills.

Source: healthday.com

Controlled-release opioid triples risk of endocarditis in injection drug users

January 23, 2020

Injection drug users prescribed controlled release hydromorphone—an opioid—are three times more likely to develop endocarditis than users prescribed other opioids, according to work published Jan. 22 in The Lancet Infectious Diseases.

For the study, Michael Silverman, MD, and colleagues at ICES, the Lawson Health Research Institute and Western University looked at de-identified heart data from hospital admissions related to injection drug use between 2006 and 2015 in Ontario, Canada. Of the 60,529 admissions they included in their dataset, 733 patients presented with infective endocarditis, a serious bacterial heart infection.

Source: cardiovascularbusiness.com

Drug to Prevent Premature Birth Divides Doctors, Insurers And FDA Experts

January 24, 2020

Doctors fear that the only drug approved to prevent preterm birth, the nation's leading cause of infant mortality and disability, will no longer be available to expectant mothers. The drug, whose brand-name version is Makena, has been in limbo since October, when an expert panel convened by the Food and

2020 Trends in Pharmacy Care: Value-Based Pharmacy and Social Determinants of Health

January 22, 2020

One of the most significant changes in the pharmacy landscape for 2020 lies within the shift from the standard fee-for-service model to a value-based care payment system. The shift demonstrates a increasing awareness surrounding the social determinants of health (SDoH) as well as the growing understanding of the value of health care providers in preventing hospitalizations and in improving overall patient outcomes.

Source: pharmacytimes.com

Travel Vaccines Promote Public Health

January 23, 2020

Vaccines are important, especially when traveling internationally. Pharmacists should advise families to ensure that they are up-to-date on all routine US vaccines. The CDC’s Adult Vaccine Assessment Tool is a great way for patients to begin determining which immunizations they may need before traveling, as it provides a survey that includes medical history, potential travel outside the United States, and risk factors.



Drug Administration reviewed the accumulated evidence and concluded that Makena is not effective in preventing preterm birth.

Source: npr.org

Newly updated formulary tool aims to help payers get early information on unapproved drugs

January 25, 2020

A formulary submission tool has been updated to enable payers to get access to drugs' product information before they are approved in order to make decisions faster.

The Food and Drug Administration (FDA) gave greater flexibility to drugmakers in 2018 to share information on unapproved products with insurers and formulary managers. The Academy of Managed Care Pharmacy (AMCP) updated its format for formulary submissions to include new ways for drug companies to share information on unapproved products.

Source: fiercehealthcare.com

When Insurance Won't Cover Drugs, Americans Make 'Tough Choices' About Their Health

January 27, 2020

The majority of Americans have health insurance that includes coverage for prescription drugs. But unfortunately that doesn't ensure that they can afford the specific drugs their doctors prescribe for them.

Source: npr.org

Individualized COPD Therapy May Reduce Exacerbations, Costs

January 28, 2020

Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death by disease in the United States. COPD is one of the most prevalent chronic diseases associated with lifelong economic burden without a cure. As the disease progresses, patients can experience exacerbations leading to a decreased quality of life, and increased costs.


Magic Mushrooms Ease Cancer Anxiety; Olanzapine/Samidorphan NDA Accepted

January 29, 2020

Just one dose of synthetic psilocybin -- the compound in magic mushrooms -- alleviated anxiety and depression in cancer patients for up to five years. (Journal of Psychopharmacology)

Based on the ENLIGHTEN program, the FDA accepted Alkermes' application for its schizophrenia and bipolar disorder treatment ALKS 3831 (olanzapine/samidorphan) with an expected action date of November.



Regeneron, U.S. health department partner to develop coronavirus treatment

February 4, 2020

The U.S. Department of Health and Human Services said on Tuesday it was partnering with Regeneron Pharmaceuticals Inc (REGN.O) to develop a treatment for the coronavirus, making the drugmaker the latest to join the race to develop a therapy.

Source: reuters.com

Abaloparatide versus Alendronate for Postmenopausal Women With Osteoporosis?

February 5, 2020

Osteoporosis remains under-diagnosed and under-treated. Osteoporotic hip fractures carry a very high morbidity and mortality, but a study published in 2014 (Solomon et al, J Bone Miner Res, doi: 10.1002/jbmr.2202) estimated the probability of osteoporosis medication use within 12 months after discharge was 28.5%. There are limited treatment options and unfortunately some negative public perception of medications to treat osteoporosis has resulted in lower treatment and compliance rates.



RECALLS

Product Type Product Description Classification Code Info Reason for Recall Recalling

Firm Drugs Entropic Labs SARM RAD-

140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302

Class II All lots Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)

Tuscano and Delucia Group (DBA Entropic Labs)

Drugs Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

Class II Lot Number: 3086746, exp. date May 2020

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Mylan Pharmaceuticals Inc.

Drugs Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

Class II Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Mylan Pharmaceuticals Inc.

Drugs Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60

Class II Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21

CGMP Deviations: Presence of NDMA impurity detected in product.

H J Harkins Company Inc dba Pharma Pac

Drugs Ranitidine Tablets, USP 150 mg a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC

Class II N102851902, Exp. 04/21 D102851801, Exp. 04/21 N102851901, Exp. 11/21 N102851903, Exp. 12/21


Denton Pharma, Inc.



Firm 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.

N102851906, Exp. 03/22 N102851904, Exp. 02/22 N102851905, Exp. 12/21 C102851901, Exp. 11/21 C102851902, Exp. 11/21 C102851903, Exp. 11/21 C102851904, Exp. 05/21 C102851905, Exp. 02/22 C102851906, Exp. 02/22 C102851907, Exp. 03/22

Drugs Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

Class II N106851901, Exp. 11/21 N106851902, Exp. 10/21 C106851901, Exp.11/21 C106851902 Exp. 10/21 C106851903 Exp. 02/22 C106851904 Exp. 11/21 C106851905 Exp. 05/22


Denton Pharma, Inc.

Drugs Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, 30 count bottles (NDC: 68788-7388-3), 60 count bottles (NDC: 68788-7388-6), 90 count bottles (NDC: 68788-7388-9), 100 count bottles (NDC: 68788-7388-1)

Class II Lot #: All lots within expiry


Preferred Pharmaceuticals, Inc



Firm Drugs Preferred Pharmaceuticals,

Inc, Ranitidine Tablets, 300 mg, Rx Only, 14 count bottles (NDC: 68788-6382-1), 30 count bottles (NDC: 68788-6382-3), 90 count bottles (NDC: 68788-6382-9), 100 count bottles (NDC: 68788-6382-0)

Class II Lot #: All lots within expiry


Preferred Pharmaceuticals, Inc

Drugs NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

Class II Lot #: PG1919025, Exp. 07/11/20; PG1919026, PG1919027, Exp. 07/16/20.

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Advanced Accelerator Applications USA, Inc.

Drugs Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

Class II Lot #: J0376034-052319, exp. date 05/2020 Lot #: J0406133-093019, exp. date 10/2020 Lot #: J038005-082719, exp. date 08/2020 Lot #: J0390280-072519, exp. date 07/2020 Lot #: J0390277-072519, exp. date 07/2020 Lot #: J0349352-012519, exp. date 01/2020

CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

RemedyRepack Inc.

Drugs MethylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA

Class III Lot #: 1901113.1, Exp JUL 2021

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare

Hikma Pharmaceuticals USA Inc.



Firm (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.

Drugs DHEA/Pregnenol One 10.25 MG Cap

Class II Lot: L61406:42 Use by: 05/06/2020

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

MPRX, Inc. dba Medical Park Pharmacy

Drugs Finasteride/Biotin 1 mg/50 mcg

Class II Lot: 60658:42 Use by: 12/28/2019



Drugs Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars




Drugs Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars

Class II Lots: 61134:42 Use by: 01/31/2020; 61302:26 Use by: 04/14/2020; 61318:42 Use by: 04/19/2020





Firm Drugs Liothyronine (T3) 80 mcg SR

cap Class II Lot: 61253:42

Use by: 04/01/2020



Drugs Liothyronine (T3) 92.5 MCG Class II Lot: 61024:99 Use by: 02/20/2020



Drugs Magic Bullet Supplement Class II Lot: 61048:99 Use by: 02/08/2020



Drugs Naltrexone 4.5 mg capsule Class II Lot: 60564:42 Use by: 02/10/2020



Drugs Progesterone 200 mg Troche




Drugs Progesterone 50 mg capsules


Labeling: Incorrect or missing lot and/or expiration date. Products

MPRX, Inc. dba Medical



Firm were compounded using expired components.

Park Pharmacy

Drugs Progesterone E4M SR 100 mg capsules




Drugs Sildenafil 200 mg Troche (Clinic)




Drugs Sildenafil 80 mg capsules Class II Lot: 61404:42 Use by: 05/06/2020



Drugs Squaric Acid 0.1% Topical Solution (Clinic) 30 mL




Drugs T3/T4 SR 9 mcg/38 mcg capsule

Class II Lot: 61296:42Use by: 04/13/2020





Firm Drugs Tadalafil 20 mg Troche Class II Lots: 61137:42

Use by: 03/08/2020; 61324:99 Use by: 04/04/2020; 60856:42 Use by: 02/02/2020



Drugs Tadalafil 6 mg Capsule Class II Lots: 61229:26 Use by: 03/25/2020; 61229:42 Use by: 03/25/2020



Drugs Testosterone Topical Cream 4%




Drugs Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704

Class II Lot #18J1081, Exp 03/10/19

Presence of Particulate Matter: Particulates observed in vials release for dispensing.

McGuff Compounding Pharmacy Services, Inc.

Drugs Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

Class II Lots: BB70, BB71 Exp. May 2020

Subpotent: Out of specification for assay at the 12-month time point.

Pharmaceutical Associates Inc

Drugs Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot

Class II Lot #: L 19173, Exp 06/20/2021

Presence of Foreign Substance; Metal contaminant visible in product

Shandex Personal Care Manufacturing Inc.



Firm Road, Deerfield, IL 60015, NDC: 0363-0137-11

(screen wire from manufacturing).

Drugs Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10

Class III Lot #: BMD8901B, Exp. Date 02/2021

Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product

Macleods Pharma Usa Inc

Drugs Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01

Class II Lot #: 1281203M, exp. date 03/2020 and 1290113M, exp. date 04/2020

GMP Deviations: Product bottle may be absent of desiccant.

Teva Pharmaceuticals USA

Drugs Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01

Class II Lot #: 1269726M, exp. date 01/2020; 1283269M, 1283270M, exp. date 03/2020; 1292992M,1292993A, exp. date 04/2020

GMP Deviations: Product bottle may be absent of desiccant.


Drugs Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

Class II Lot #:11E0585, Exp. October 2023


Spectrum Laboratory Products

Drugs Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA;

Class II Lot #: ATA318099C, Exp 12/2020

Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg

Graviti Pharmaceuticals Private Limited



Firm Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.

Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.

Drugs Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.

Class II Lot #: 19122552, Exp 7/31/2021

cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.

Ascend Laboratories LLC

Drugs ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

Class II a) H19E83 Exp. 11/20, E19A82 Exp. 05/31/2020; b) H19B20 Exp. 11/20, G19D77 Exp. 05/20, C19D84 Exp. 05/20, D19A77 Exp. 05/20, D19E40 Exp. 05/20; c) I19C45 Exp. 11/30/2020, E19E42 Exp. 11/30/2020, G19B41 Exp. 11/30/2020, H19C77 Exp. 11/30/2020, E19A34 Exp. 05/31/2020; d) H19B61 Exp. 11/30/2020, H19C82 Exp.

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

PD-Rx Pharmaceuticals, Inc.



Firm 11/30/2020, C19A18 Exp. 05/31/2020, C19B13 Exp. 05/31/2020, D19B77 Exp. 05/31/2020, E19B76 Exp. 05/31/2020; e) I19B41 Exp. 11/30/2020, D19D51 Exp. 05/31/2020, F19C33 Exp. 05/31/2020

Drugs Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.

Class III Lot #: 19140414, Exp 12/2020

Failed Dissolution Specifications: low out of specification results for dissolution testing.

Ascend Laboratories LLC

Drugs Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09

Class III Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

Macleods Pharma Usa Inc

Drugs Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, and Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc.

Class III Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020

Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential

UNICHEM PHARMACEUTICALS USA INC



Firm East Brunswick, NJ 08816. NDC 29300-135-01

migration of Benzophenone at very low level into product from container label.

Drugs Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.

Class I Lot #: 331771, Exp. June 2021

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

Taro Pharmaceuticals U.S.A., Inc.

Drugs Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01

Class II Lot #: 1332796 A, Exp 11/2020

CGMP deviations: Product bottle may be absent of desiccant.


Drugs Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01

Class II Lot # 1332799A, Exp 11/2020

CGMP deviations: Product bottle may be absent of desiccant.


Drugs Kushim Tablets (Gushim) 45-count packages, Label in foreign language

Class II Lot #: H003 Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine

B AND A TRADING CORPORATION

Drugs Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC

Class II Lot #s: 08133DK (tray) 08-133-DK (vial); 08134DK (tray) 08-134-DK (vial), Exp. 2/1/2021.

Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which

Pfizer Inc.



Firm 00409-9094-12 (vial), 00409-9094-22 (tray).

may result in lack of assurance of sterility.

Drugs Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.

Class II Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020

cGMP Deviations Zydus Pharmaceuticals USA Inc

Drugs Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.

Class II Lot #: CY0937, Exp 12/2021

Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Pfizer Inc.

Drugs Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.

Class II Lot #: CY0963, Exp 07/2022

Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Pfizer Inc.

Drugs Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by:

Class II Lot: 19H359 Exp. August 2022

Microbial Contamination of

Efficient Laboratories, Inc.



Firm Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

Non-Sterile Products

Drugs Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1

Class II Lot: 19F332 Exp. June 2022

Microbial Contamination of Non-Sterile Products


Drugs New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5

Class II Lot: 19B42 Exp. February 2022

Microbial Contamination of Non-Sterile Products


Drugs Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20

Class II Lot #: SM8719040-A, Exp. Date 02/2021

Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie

AuroMedics Pharma LLC

Drugs Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

Class II Lot #: 364667, Exp 12/20/2019

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

Akorn Inc

Drugs Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.

Class III Lot Number: 9698818; labeled expiration AUG 2022; actual expiration APR 2022

Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.

Par Pharmaceutical Inc.



Firm Drugs Leader Extra Strength

Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8

Not Yet Classified

Lot #: 193005, Exp. Date 08/21

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.

Contract Pharmacal Corporation

Drugs Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA

Not Yet Classified

Lot #: 193005, Exp. Date 08/21

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.

Contract Pharmacal Corporation

Drugs Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11

Not Yet Classified

Lot #:180276A, Exp date 02/29/2020

Failed Dissolution Specifications: Low out of specification results obtained during stability testing.

American Health Packaging

Drugs Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00

Not Yet Classified

Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020

Presence of Particulate Matter: Medication relabeled at facility was

RemedyRepack Inc.



Firm recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

Drugs Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

Not Yet Classified

Lot: K79A, K79B, K79C, exp 3/31/2021; XB2W, Y23L, Y23V, exp 5/31/2021; 19N1793000, 19N1895942, 19N1952247, 19N1884668, 19N1936498, 19N1936583, exp 3/31/2021; 19N1920630, 19N1958240, exp 4/30/2021; 19N1957675, M926001MA, M926002MA, M926003MA, M926004MA, M926005MA, M926006MA, M926007MA, M926008MA, M926009MA, M926201MA, M926202MA, exp 5/31/2021; M926201MB, M926202MB, M926203MB, M926204MB, M926205MB, M926206MB, M926207MB, M926208MB,

Product recalled due to absence of a warning statement on the product label. Ask a doctor before use if you have a sodium-restricted diet.

GSK Consumer Health, Inc



Firm M926209MB, exp 2/28/2021

Drugs Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06

Not Yet Classified

Lot #: H900330, exp. date 11/2020.

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

Lupin Pharmaceuticals Inc.

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


CURRENT DRUG SHORTAGES

Tice BCG intravesical injection January 17, 2020 Reason for the Shortage

• Increased global demand • Merck is the only source of BCG Live(Intravesical) in the U.S and many other countries

Estimated Resupply Dates • Merck has Tice BCG on allocation

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=519

Calcium Acetate Oral Capsules and Tablets January 17, 2020 Reason for the Shortage

• Amneal did not provide a reason for the shortage. • Cipla has calcium acetate capsules temporarily unavailable. • Hikma did not provide a reason for the shortage. • Heritage did not provide a reason for the shortage. • Major did not provide a reason for the shortage. • Marlex did not provide a reason for the shortage. • Nephro-Tech has Calphron tablets available. • Nostrum has calcium acetate capsules available. • Perrigo has temporarily discontinued calcium acetate tablets. The company cannot estimate a

relaunch date. • Sandoz has calcium acetate capsules available.

Estimated Resupply Dates • Amneal did not provide a reason for the shortage. • Cipla has calcium acetate capsules temporarily unavailable. • Hikma did not provide a reason for the shortage. • Heritage did not provide a reason for the shortage. • Major did not provide a reason for the shortage. • Marlex did not provide a reason for the shortage. • Nephro-Tech has Calphron tablets available. • Nostrum has calcium acetate capsules available. • Perrigo has temporarily discontinued calcium acetate tablets. The company cannot estimate a

relaunch date. • Sandoz has calcium acetate capsules available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=617 Carbidopa and Levodopa Extended-Release Tablets January 17, 2020 Reason for the Shortage

• Accord has discontinued carbidopa and levodopa 25 mg/100 mg extended-release tablets. The 50 mg/200 mg tablets were 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

• All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=349 Ceftazidime Injection January 17, 2020 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 1 gram and 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 May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=63 Droperidol Injection January 17, 2020 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 available in limited supply. • Pfizer has droperidol 2.5 mg/mL ampules on back order and the company estimates a release

date of March 2021. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=603 Heparin Injection January 17, 2020 Reason for the Shortage

• Fresenius Kabi has heparin injection available. • 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 • Hikma has 1,000 unit/mL 2 mL and 30 mL vials, 5,000 unit/mL 2 mL and 10 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 vials are available in limited supply. 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 February 2020. There are short-dated 10,000 unit/mL 0.5 mL Carpuject syringes available with an expiration date of June 2020. The 10,000 unit/mL 1 mL vials are available in limited supply. The 1,000 unit/mL 10 mL and 30 mL vials are available in limited supply. There are short-dated 1,000 unit/mL 1 mL vials available with an expiration date of May 2020.

• Sagent has heparin 1,000 unit/mL 10 mL vials on back order and the company estimates a release date of February 2020. The 1,000 unit/mL vials are on allocation. The 10,000 unit/mL 1 mL vials are on allocation. The 20,000 unit/mL 1 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353 Hydroxyprogesterone Caproate Injection January 17, 2020 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 and the 1 mL vials in late-2019. • 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 Ranitidine Injection January 17, 2020 Reason for the Shortage

• Mylan did not provide a reason for the shortage. • 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

• Mylan Institutional has ranitidine injection on back order and the company estimates a release date in late-February 2020.

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

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



Acetylcysteine Oral and Inhalation Solution January 21, 2020 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 on shortage due to manufacturing delays. • 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. • Pfizer has acetylcysteine solution 200 mg/mL 30 mL 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=43 Olanzapine Intramuscular Injection January 21, 2020 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 Triamcinolone Acetonide Intravitreal Injection January 21, 2020 Reason for the Shortage

• Novartis has Triesence on shortage due to manufacturing delays. Estimated Resupply Dates

• Novartis has Triesence 40 mg/mL 1 mL vials on limited allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=598 Vinblastine Sulfate Injection January 21, 2020 Reason for the Shortage

• Fresenius Kabi had 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.



5% Lidocaine and 7.5% Dextrose Injection January 22, 2020 Reason for the Shortage

• Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on shortage due to manufacturing delays.

• Pfizer is the sole supplier of this combination. Estimated Resupply Dates

• Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on long-term back order and the company estimates a release date of January 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=253 Bisacodyl Suppositories January 22, 2020 Reason for the Shortage

• G&W Laboratories discontinued bisacodyl suppositories. • Geri-Care has bisacodyl suppositories available. • Major has bisacodyl suppositories available. Major updated their NDC numbers in September

2019. • Perrigo has bisacodyl suppositories available. • Rugby Laboratories has bisacodyl suppositories available. 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. • Geri-Care has bisacodyl 10 mg suppositories in 12 and 100 count available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=565 Doxorubicin Injection January 22, 2020 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 • Athenex has doxorubicin 2 mg/mL 25 mL vials on back order and the company cannot estimate

a release date. • Hikma has doxorubicin 2 mg/mL 5 mL and 10 mL vials on back order and the company estimates

a release date of late-January 2020. The 2 mg/mL 100 mL vials are on allocation. • Pfizer has doxorubicin 2 mg/mL 75 mL and 100 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108 Etomidate Injection January 22, 2020 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 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 March 2020. 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 Fluconazole Injection January 22, 2020 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. • Sagent had fluconazole injection available. • Woodward Pharma acquired fluconazole in sodium chloride from Renaissance Lakewood

Pharmaceuticals in August 2019. The 10 count sizes have been discontinued. Estimated Resupply Dates

• Not provided


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=318 Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution January 22, 2020 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.

• OCuSOFT discontinued Flucaine in January 2020. Estimated Resupply Dates

• Altaire has fluorescein/proparacaine 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 Hydroxyzine Pamoate Oral Capsules January 22, 2020 Reason for the Shortage

• Amneal has hydroxyzine pamoate capsules available. • Avet (formerly 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. • Sandoz has hydroxyzine pamoate capsules available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Pfizer has Vistaril 25 mg capsules in 100 count bottles on back order and the company estimates

a release date of July 2020. • Teva has hydroxyzine pamoate capsules 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=545 Levetiracetam Extended-Release Tablets January 22, 2020 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 back order and the

company estimates a release date of February 2020. • 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 back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=583 Recombinant Zoster Vaccine (Shingrix) January 22, 2020 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 Sodium Phosphate Injection January 22, 2020 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 August 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Daptomycin Injection January 23, 2020 Reason for the Shortage

• BE Pharmaceuticals has daptomycin available. • Dr. Reddy's has daptomycin available. • Fresenius Kabi has daptomycin available. • Mylan Institutional has daptomycin available. • Pfizer discontinued daptomycin in December 2019. • 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.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=467 Deferoxamine Injection January 23, 2020 Reason for the Shortage

• Fresenius Kabi had deferoxamine on shortage due to increased demand. • Pfizer had deferoxamine on shortage due to manufacturing delays. • Novartis has Desferal available.


• Alvogen did not provide a reason for the shortage. Alvogen discontinued the 500 mg vials in late-2019.

• Apo-Pharma launched deferoxamine injection in mid-2018. Estimated Resupply Dates

• Alvogen has short-dated deferoxamine 2 gram vials available with an expiration date of June 2020.

• Pfizer has deferoxamine 500 mg vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393 Aminocaproic Acid Injection January 24, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Pfizer has aminocaproic acid injection on shortage due to manufacturing delays.

Estimated Resupply Dates • American Regent has aminocaproic acid 250 mg/mL 20 mL vials available in limited supply. • Pfizer has aminocaproic acid 250 mg/mL 20 mL 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=629 Aminophylline Injection January 24, 2020 Reason for the Shortage

• Pfizer had aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has aminophylline 25 mg/mL 10 mL and 20 mL vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407 Atropine Sulfate Injection January 24, 2020 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 on back order and the company cannot

estimate a release date. The 1 mg/mL 1 mL vials are available in limited supply. • Hikma has atropine 0.4 mg/mL 20 mL vials on allocation. • Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company

estimates release dates of February 2020. The 0.1 mg/mL 10 mL Ansyr syringes are on back order and the company estimates a release date of April 2020. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates release dates of August 2020. The 0.05 mg/mL 5 mL Ansyr syringes are available with an expiration date of March 2020.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 Atropine Sulfate Ophthalmic Ointment January 24, 2020 Reason for the Shortage

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

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

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=602 Labetalol Injection January 24, 2020 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 vials on back order and the company estimates a release

date of mid-February 2020. • Pfizer has labetalol 5 mg/mL 40 mL vials on back order and the company estimates a release

date of May 2020. The 5 mg/mL 20 mL vials and 4 mL Carpuject syringes are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Midazolam Injection January 24, 2020 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 5 mL vials on back order and the company estimates a release

date of April 2020. • Fresenius Kabi has short-dated midazolam 5 mg/mL 1 mL syringes available with expiration

dates of <4 months. • Pfizer has midazolam 1 mg/mL 2 mL Carpuject syringes and 5 mg/mL 1 mL Carpuject syringes on

back order and the company estimates a release date of June 2021. The 1 mg/mL 2 mL iSecure syringes are on back order and the company estimates a release date of December 2021. Midazolam 1 mg/mL 10 mL multi-dose vials are on back order and the company estimates a release date of March 2020.



Morphine Injection January 24, 2020 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.

Estimated Resupply Dates • Pfizer has morphine 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1

mL iSecure syringes, and 10 mg/mL 1 mL iSecure syringes on back order and the company estimates a release date of December 2021. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of April 2020. The 50 mg/mL 50 mL vials are 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=41 Nalbuphine Injection January 24, 2020 Reason for the Shortage

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

• Pfizer has nalbuphine 10 mg/mL 1 mL ampules and 20 mg/mL 1 mL ampules on back order and the company estimates a release date of June 2020. The 20 mg/mL 10 mL vials are on back order and the company estimates a release date of November 2020. The 10 mg/mL 10 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=599 Nitroglycerin Injection January 24, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Nitroglycerin premixed bags are not affected by this shortage.

Estimated Resupply Dates • American Regent has nitoglycerin 5 mg/mL 10 mL vials available in limited supply.



Tropicamide 1% Ophthalmic Solution January 24, 2020 Reason for the Shortage

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

Estimated Resupply Dates • Akorn has 1% tropicamide 15 mL bottles on allocation. • Bausch Health has 1% tropicamide 2 mL bottles on back order and the company estimates a

release date of early-April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=547 Azithromycin Injection January 27, 2020 Reason for the Shortage

• Apotex has discontinued azithromycin injection. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi had azithromycin injection on shortage due to increased demand. • Pfizer has azithromycin injection on shortage due to manufacturing delays. • Slate Run Pharmaceuticals has azithromycin injection available. • Sun Pharma is not currently manufacturing azithromycin injection.

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

releasing product as it becomes available. • Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a

release date of June 2021. Zithromax 500 mg vials are 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=380 Bupivacaine Injection January 27, 2020 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.


• 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 March 2020. The 0.5% bupivacaine 10 mL preservative-free vials are available in limited supply. 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 March 2020.

• 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 June 2020 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of August 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 February 2020 for the 10 mL vials and June 2020 for the 30 mL vials. The 0.5% 50 mL vials are on back order and the company estimates a release date of June 2020. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of March 2020 for the 10 mL vials and April 2020 for the 30 mL vials.


Fluorometholone Ophthalmic Ointment January 27, 2020 Reason for the Shortage

• Allergan did not provide a reason for the shortage. They are the sole suppliers of fluorometholone ointment.

• Fluorometholone ophthalmic suspension is not affected by this shortage. Estimated Resupply Dates

• Allergan has FML ophthalmic ointment on long-term back order and the company estimates a release date of June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=613 Furosemide Injection January 27, 2020 Reason for the Shortage

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

demand. Estimated Resupply Dates

• Pfizer has furosemide 10 mg/mL 4 mL and 10 mL syringes on back order and the company estimates a release date of December 2020. There are short-dated 2 mL vials available with an expiration date of May 2020.



Guanfacine Hydrochloride Tablets January 27, 2020 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 late-April 2020 https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=508 Levetiracetam Injection January 27, 2020 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. • Dr. Reddy's has levetiracetam injection available. • Fresenius Kabi has levetiracetam injection available. • Hikma has product available. • Mylan has levetiracetam injection available. • Pfizer did not provide a reason for the shortage. • Sagent did not provide a reason for the shortage. • Sun Pharma are not manufacturing levetiracetam injection at this time. • UCB has product available. • X-Gen did not provide a reason for the shortage.

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. • Pfizer has levetiracetam 100 mg/mL 5 mL vials available in limited supply. • Sagent 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 cannot estimate

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


Norepinephrine Bitartrate Injection January 27, 2020 Reason for the Shortage

• Baxter has norepinephrine injection available. • Hikma has norepinephrine injection available. • Mylan Institutional did not provide a reason for the shortage. • Pfizer had Levophed vials on shortage due to manufacturing delays. The ampules were

discontinued in December 2019. • Teva had norepinephrine injection on allocation due to increased demand.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=292 Rocuronium Injection January 27, 2020 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 available. • Sagent has rocuronium available. • Sandoz has rocuronium available. • X-Gen has rocuronium available.

Estimated Resupply Dates • Athenex has short-dated rocuronium 10 mg/mL 5 mL and 10 mL vials available. • AuroMedics has rocuronium 10 mg/mL 5 mL vials on intermittent back order and the company

is releasing product as it becomes available. • Pfizer has rocuronium 10 mg/mL 5 mL vials available in limited supply. The 10 mL vials are 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=290 Vancomycin Hydrochloride Injection January 27, 2020 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. • Baxter has vancomycin 750 mg/150 mL 0.9% sodium chloride premixed bags available in limited

supply. • Pfizer has vancomycin 750 mg ADD-Vantage vials available in limited supply. The 500 mg ADD-

Vantage vials are on back order and the company estimates a release date of May 2020. The 500 mg regular vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 50% Dextrose Injection January 28, 2020 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 available in limited supply. The 50% dextrose

50 mL Ansyr syringes are available in limited supply. The 50% dextrose 50 mL vials are on back order and the company estimates a release date of February 2020.

• 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 Bivalirudin Injection January 28, 2020 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 has bivalirudin available. • Pfizer has bivalirudin on shortage due to manufacturing delays. • Sandoz has bivalirudin available.

Estimated Resupply Dates • AuroMedics has bivalirudin 250 mg vials on intermittent back order and the company is

releasing supplies as they become available. • Pfizer has bivalirudin 250 mg vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=569 Dobutamine Injection January 28, 2020 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.

• Pfizer has dobutamine 4 mg/mL in 250 mL bags on back order and the company estimates a release date of March 2020. The 1 mg/mL 250 mL bags are on back order and the company estimates a release date of April 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296 Ketamine Injection January 28, 2020 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 June 2020. The 100 mg/mL 5 mL vials are available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Methocarbamol Tablets January 28, 2020 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. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423 Pentamidine Isethionate January 28, 2020 Reason for the Shortage

• Fresenius Kabi had Nebupent and Pentam 300 on back order due to a short-term manufacturer delay.

• Seton Pharmaceuticals has pentamidine isethionate injection on shortage due to high demand. Estimated Resupply Dates

• Seton Pharmaceuticals has pentamidine isethionate 300 mg vials for injection on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=584


Sodium Acetate Injection January 28, 2020 Reason for the Shortage

• American Regent is not currently marketing sodium acetate injection. • Fresenius Kabi has sodium acetate injection available. • 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 Sufentanil Injection January 28, 2020 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 5 mL 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=376 0.9% Sodium Chloride Small Volume Bags (<150 mL) January 29, 2020 Reason for the Shortage

• Baxter has 0.9% sodium chloride small volume bags available. • BBraun has 0.9% sodium chloride small volume bags available. • BD has 0.9% sodium chloride small volume bags available. • Fresenius Kabi has 0.9% sodium chloride small volume bags available. • ICU Medical did not provide a reason for the shortage. • Pfizer had 0.9% sodium chloride small volume presentations on shortage due to increased

demand. Estimated Resupply Dates

• ICU Medical has 0.9% sodium chloride 50 mL and 100 mL VisIV bags available to contracted customers only.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352 Acetazolamide Injection January 29, 2020 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Mylan Institutional has acetazolamide sodium injection available. • X-Gen did not provide a reason for the shortage.



• Hikma has acetazolamide sodium 500 mg vials on back order and the company estimates a release date of late-February 2020.

• X-Gen has acetazolamide sodium 500 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=528 Amyl Nitrite Inhalation January 29, 2020 Reason for the Shortage

• James Alexander has amyl nitrite inhalation on shortage due to manufacturing issues. Estimated Resupply Dates

• James Alexander has amyl nitrite inhalation on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=505 Asparaginase Erwinia chrysanthemi January 29, 2020 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 available. • 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 Caffeine and Sodium Benzoate Injection January 29, 2020 Reason for the Shortage

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

• American Regent has caffeine and sodium benzoate 125 mg/mL in 2 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=630 Doxycycline Hyclate Injection January 29, 2020 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.




Hyoscyamine Sulfate Injection January 29, 2020 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • BPI Labs has hyoscyamine sulfate injection available.

Estimated Resupply Dates • Mylan Institutional has Levsin 1 mL ampules on back order and the company estimates a release

date of late-April to early-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=615 Nitrofurantoin Oral Suspension January 29, 2020 Reason for the Shortage

• Amneal stated the shortage of nitrofurantoin oral suspension is due to manufacturing delays. • Casper Pharma stated the Furadantin shortage is due to manufacturing delays. • Lupin is no longer manufacturing this product. • Nostrum has nitrofurantoin oral suspension available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Amneal has nitrofurantoin oral suspension temporarily unavailable and the company cannot

estimate a release date. • Casper has Furadantin oral suspension on back order and the company cannot estimate a

release date. • Teva has nitrofurantoin oral suspension temporarily unavailable and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=433 Piperacillin and Tazobactam Injection January 29, 2020 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 has piperacillin/tazobactam injection available. • Fresenius Kabi has piperacillin/tazobactam injection available. • Mylan Institutional has piperacillin/tazobactam injection available. • Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays. • Sagent has piperacillin/tazobactam injection available. • Sandoz has piperacillin/tazobactam injection available. • WG Critical Care has piperacillin/tazobactam available. • Wockhardt did not provide a reason for the shortage • X-Gen has discontinued all piperacillin/tazobactam presentations.



• Apotex has piperacillin/tazobactam 40.5 gram bulk vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has piperacillin/tazobactam 2.25 gram vials on back order and the company estimates a release date in mid- to late-February 2020.

• Pfizer has Zosyn 2.25 gram, 3.375 gram, 4.5 gram, and 40.5 gram vials on back order and the company estimates a release date of March 2021.

• Wockhardt has piperacillin/tazobactam 2.25 gram and 3.375 gram vials on allocation. The 4.5 gram and 40.5 gram vials 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=158 Valsartan and Hydrochlorothiazide Tablets January 29, 2020 Reason for the Shortage

• Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

• Solco and Teva valsartan/hydrochlorothiazide tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

• Solco and Teva discontinued valsartan/hydrochlorothiazide tablets in July 2018. • Aurobindo refused to provide updated availability information. • Lupin has valsartan/hydrochlorothiazide tablets on back order because they are holding and

testing product for impurities. • Macleods refuses to provide updated availability information. • Repackagers may have some presentations affected depending on the source supplier.

Estimated Resupply Dates • Alembic has all valsartan/hydrochlorothiazide presentations on allocation. • Lupin has all valsartan/hydrochlorothiazide presentations on back order and the company

cannot estimate a release date. • Mylan has all valsartan/hydrochlorothiazide 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=445 Amiodarone Injection January 30, 2020 Reason for the Shortage

• Baxter had Nexterone premixed bags on shortage due to manufacturing delays. • Mylan Institutional did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count

presentation was discontinued in December 2018. • Sagent discontinued amiodarone 50 mg/mL 3 mL syringes in June 2019.



• AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on back order and the company cannot estimate a release date.

• Fresenius Kabi has amiodarone 50 mg/mL 9 mL vials on back order and the company estimates a release date of 1st quarter 2020.

• Hikma has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of mid-February 2020.

• Mylan Institutional has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on back order and the company estimates a release date of late-February 2020 for the 3 mL vials, mid-March 2020 for the 9 mL vials, and mid- to late-February 2020 for the 18 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374 Bumetanide Injection January 30, 2020 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 vials on back order and the company estimates a

release date of August 2020. The 10 mL vials are available in limited supply. • Hikma has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307 Cefuroxime Sodium Injection January 30, 2020 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

• Teligent is estimating a relaunch of Zinacef 750 mg vials and 1.5 gram vials in February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13 Cyclosporine Oral Solution January 30, 2020 Reason for the Shortage

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

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

• Novartis has Neoral oral solution on back order and the company cannot estimate a release date. A limited emergency supply is available for drop ship.

• Novartis has Sandimmune oral solution on back order and the company cannot estimate a release date. A limited emergency supply is available for drop ship.


• Teva has cyclosporine modified oral solution on back order and the company estimates a release date of late-June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=596 Diltiazem Hydrochloride Injection January 30, 2020 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.

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

demand due to current market conditions. Estimated Resupply Dates

• Akorn has diltiazem 5 mg/mL 5 mL and 10 mL vials on back order and the company estimates a release date of March 2020. There are short-dated vials available. The 25 mL vials are on allocation.

• Hikma has diltiazem 5 mg/mL 5 mL, 10 mL, and 25 mL vials on allocation. • 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 Famotidine Tablets January 30, 2020 Reason for the Shortage

• Alembic has famotidine tablets on allocation due to increased demand. • Mylan discontinued famotidine tablets in all presentations in April 2019. • Teva did not provide a reason for the shortage. • Aurobindo refuses to provide availability information. • Dr. Reddy's discontinued famotidine tablets in all presentations. • Bausch Health did not provide a reason for the shortage.

Estimated Resupply Dates • Alembic has famotidine 20 mg and 40 mg tablets on allocation. • Bausch has Pepcid 40 mg tablets in 30 count bottles on back order and the company estimates a

release date of late-February 2020. • Teva has famotidine 20 mg tablets in 500 and 1000 count bottles on back order and the

company estimates a release date of late-February 2020 for the 500 count and early-February 2020 for the 1000 count bottles. The 40 mg tablets in 100 count and 500 count bottles are on back order with an estimated release date of early-February 2020.



Hydroxyethyl Starch in Sodium Chloride Injection January 30, 2020 Reason for the Shortage

• BBraun did not provide a reason for the Hespan shortage. • Pfizer has 6% hetastarch in 0.9% sodium chloride injection available. • Pfizer discontinued Voluven in January 2020.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=454 Hypromellose Ophthalmic Solution January 30, 2020 Reason for the Shortage

• Akorn has Gonak on shortage due to lack of raw materials. • HUB Pharmaceuticals is planning on relaunching Goniovisc in late-2020. • Altaire has Goniotaire on shortage due to a voluntary recall. • OcuSoft did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on back order and the company

cannot estimate a release date. • Altaire has Goniotaire 2.5% ophthalmic solution 15 mL bottles on back order and the company

cannot estimate a release date. • Hub Pharmaceuticals has Goniovisc on long-term back order and the company estimates a

relaunch date of late-2020. • OCuSOFT has Goniosoft 2.5% 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=437 Metronidazole Hydrochloride Injection January 30, 2020 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • BBraun has metronidazole injection available. • Pfizer has metronidazole injection available. • Sagent launched metronidazole injection in October 2019.

Estimated Resupply Dates • Baxter has metronidazole 100 mL bags (NDC 36000-0001-24) on back order and the company

cannot estimate a release date. • Pfizer has metronidazole 100 mL bags in 24 count available in limited supply.



Ondansetron Hydrochloride Injection January 30, 2020 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. The iSecure syringes

were discontinued in January 2020. • Sagent has ondansetron injection available. • Novartis discontinued Zofran 20 mL vials in May 2018.

Estimated Resupply Dates • Athenex has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a

release date of April 2020. The 20 mL vials are on intermittent back order and the company is allocating product upon release.

• AuroMedics has ondansetron 2 mg/mL 2 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-February 2020.

• Hikma has ondansetron 2 mg/mL 20 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405 Buprenorphine Hydrochloride Injection January 31, 2020 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 Buspirone Tablets January 31, 2020 Reason for the Shortage

• Accord has buspirone tablets available. • Apnar did not provide a reason for the shortage. • Mylan Has buspirone tablets available. • Par has buspirone tablets available. • Teva has buspirone tablets available. • Zydus has buspirone tablets available.


Estimated Resupply Dates • 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 Melphalan Injection January 31, 2020 Reason for the Shortage

• Dr. Reddy's has melphalan injection available. • Mylan Institutional has melphalan injection available. • Par did not provide a reason for the shortage. • Sagent is not currently marketing melphalan injection.

Estimated Resupply Dates • Fresenius Kabi has short-dated melphalan 50 mg vials available with an expiration date of <7

months. • Par has melphalan 50 mg 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=525 Bacitracin for Injection February 3, 2020 Reason for the Shortage

• FDA requested that all manufacturers of bacitracin for injection voluntarily withdraw their product from the market. More information is available at the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market

Estimated Resupply Dates • FDA requested that all manufacturers of bacitracin for injection voluntarily withdraw their

product from the market. More information is available at the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market. All products will be discontinued.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=631 Immune Globulin, Intravenous or Subcutaneous (Human) February 3, 2020 Reason for the Shortage

• ADMA Biologics has Bivigam on allocation through BioCare SD. • CSL Behring has Hizentra and Privigen on shortage due to increased demand. • Grifols has Gamunex-C and Flebogamma on shortage due to increased demand. • Kedrion Biopharma has Gammaked available to current customers. • Octapharma has Octagam on shortage due to increased demand. • Takeda has HyQvia, Cuvitru, and Gammagard on shortage due to increased demand.

Estimated Resupply Dates • ADMA Biologics has Asceniv 10% liquid and Bivigam 10% on allocation through a distribution

partner. • CSL Behring is releasing Hizentra and Privigen regularly and distributors are allocating product.


• Grifols is releasing Gamunex-C and Flebogamma regularly and distributors are allocating product.

• Grifols has Xembify 20% solution on allocation through distributors. • Kedrion has Gammaked on allocation to its current customers. • Octapharma is releasing Octagam regularly and distributors are allocating product. • Takeda has Cuvitru and HyQvia on allocation and the company is reviewing all orders. • Takeda is reviewing all Gammagard Liquid orders and the company is allocating product as it

becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=527 Bacitracin Ophthalmic Ointment February 4, 2020 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 bactracin ophthalmic ointment and Perrigo distributes the product. Estimated Resupply Dates

• Perrigo has bacitracin ophthalmic ointment on back order and the company estimates a release date of mid-February 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=582 Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection February 4, 2020 Reason for the Shortage

• Accord has dexmedetomidine vials available. • Akorn is no longer manufacturing dexmedetomidine vials. • Athenex has dexmedetomidine vials available. • AuroMedics 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. • Mylan has dexmedetomidine vials available. • Par has dexmedetomidine vials available. • Pfizer has dexmedetomidine vials available. • Sandoz did not provide a reason for the shortage. • Sun Pharma is no longer manufacturing dexmedetomidine. • Teva discontinued dexmedetomidine vials in July 2019. • WG Critical Care has dexmedetomidine vials available.

Estimated Resupply Dates • AuroMedics has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates

a release date of late-February 2020.


• Sandoz 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 Disulfiram Tablets February 4, 2020 Reason for the Shortage

• Alvogen has the product on shortage due to shipping delays. • 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 cannot estimate a

release date. • 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 Griseofulvin Oral Presentations February 4, 2020 Reason for the Shortage

• Amneal did not provide a reason for the shortage. • Cipla did not provide a reason for the shortage. • Rising discontinued griseofulvin products. • Sandoz has griseofulvin tablets available. • Teva has griseofulvin suspension available.

Estimated Resupply Dates • Amneal has griseofulvin 125 mg tablets on back order and the company cannot estimate a

release date. • Cipla has griseofulvin 125 mg/5 mL suspension on back order and the company estimates a

release date in April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=579 Ketorolac Injection February 4, 2020 Reason for the Shortage

• Alvogen did not provide a reason for the shortage. • Amphastar has discontinued ketorolac injection. • 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 • Almaject (Alvogen) has ketorolac 15 mg/mL and 30 mg/mL 1 mL vials on back order and the

company estimates a release date of late-February 2020. The 30 mg/mL 2 mL vials are on back order and the company estimates a release date of mid-February 2020.

• Athenex has ketorolac 30 mg/mL 1 mL vials for intramuscular injection on back order and the company estimates a release date of February 2020.

• Fresenius Kabi has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of late-March to early-April 2020. 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 mid- to late-February 2020.

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

• Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of March 2020. The 30 mg/mL 2 mL Carpuject syringes for intramuscular injection are on back order and the company estimates a release date of August 2020. The 30 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of December 2021.

• 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 Melphalan Tablets February 4, 2020 Reason for the Shortage

• Apo-Pharma did not provide a reason for the shortage. Estimated Resupply Dates

• Apo-Pharma has Alkeran 2 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=472 Docusate Sodium Oral Liquid in Bulk Bottles February 5, 2020 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-February 2020. Product is being allocated as it becomes available.


• Geri-Care discontinued Diocto liquid in 473 mL bottles the company plans to relaunch the product in the 2nd or 3rd quarter of 2020.

• Lannett has Silace 50 mg/5 mL liquid and 60 mg/15 mL syrup in 473 mL bottles on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=585 Hydralazine Injection February 5, 2020 Reason for the Shortage

• Akorn has hydralazine available. • American Regent is not currently marketing hydralazine injection. • Fresenius Kabi has hydralazine available. • X-Gen did not provide a reason for the shortage.

Estimated Resupply Dates • X-Gen has hydralazine 20 mg/mL 1 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=431 Neomycin and Polymyxin B Sulfates Genitourinary Irrigant February 5, 2020 Reason for the Shortage

• X-Gen did not provide a reason for the shortage. • Pfizer has Neosporin ampules available.

Estimated Resupply Dates • X-Gen has neomycin and polymyxin B sulfate 40 mg - 200,000 unit/mL 20 mL multidose vials on

back order and the company estimates a release date of mid-February 2020. Neomcyin and polymyxin B sulfate 40 mg - 200,000 unit/mL 1 mL ampules in 10 and 50 count boxes are on back order and the company estimates a release date in early-April 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=621 Sterile Water for Injection – Small Volume Vials February 5, 2020 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 mid-February 2020. The 5 mL vials are on back order and the company estimates a release date of early-March 2020.



Valsartan Tablets February 5, 2020 Reason for the Shortage

• Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

• Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

• Major, Solco, and Teva discontinued valsartan tablets in July 2018. • Alembic, Aurobindo, Cadista, Macleods, and Novartis are not affected by this recall. • Aurobindo, and Macleods refuse to provide updated availability information. • Cadista did not provide a reason for the shortage. • Lupin is not actively marketing valsartan tablets. • Mylan did not provide a reason for the shortage. • Repackagers may have some presentations affected depending on the source supplier.

Estimated Resupply Dates • Alembic has valsartan 80 mg tablets on allocation. The 40 mg tablets, 160 mg tablets, and 320

mg tablets are on back order and the company estimates a release date of mid-February 2020. • Cadista has all valsartan tablets on back order and the company estimates a release date of late-

February 2020 for the 40 mg tablets, early-March 2020 for the 80 mg tablets, and early-April 2020 for the 160 mg and 320 mg tablets.

• Camber has valsartan tablets on temporary discontinuation and the company cannot estimate a release date.

• Mylan has valsartan 160 mg and 320 mg tablets on back order and the company estimates a release date of late-February 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Tacrolimus Extended-Release Capsule and Tablets February 7, 2020 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 Benzylpenicilloyl Polylysine February 10, 2020 Reason for the Shortage

• ALK-Abello has PRE-PEN on shortage due to manufacturing problems. Estimated Resupply Dates

• Alk-Abello has PRE-PEN on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=633


Erythromycin Ophthalmic Ointmnet February 10, 2020 Reason for the Shortage

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

Estimated Resupply Dates • Bausch Health has erythromycin 3.5 gram ophthalmic ointment on back order and the company

estimates a release date of mid-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540 Amino Acid Products February 12, 2020 Reason for the Shortage

• Baxter has Premasol, Travasol, Prosol, and Clinisol available. • BBraun did not provide a reason for the shortage. • ICU Medical did not provide a reason for the shortage.

Estimated Resupply Dates • Baxter has Travasol 10% in 500 mL bags in limited supply. • BBraun has Trophamine, Plenamine, FreAmine III, and HepatAmine on allocation to contracted

customers. Product will be allocated as it becomes available. ProcalAmine is on intermittent back order and the company is releasing product as it becomes available.

• ICU Medical has Aminosyn II 15% 2000 mL bags and Aminosyn-PF 10% in 1000 mL bags available to contracted customers only.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=564 Amphetamine Mixed Salts, Immediate-Release Tablets February 12, 2020 Reason for the Shortage

• Aurobindo refuses to provide updated availability information. • Sun Pharma discontinued amphetamine mixed salts in 2019. • Zydus has amphetamine mixed salts available. • Mylan did not provide a reason for the shortage • Teva has brand name Adderall and generic amphetamine mixed salts available. • Mallinckrodt has amphetamine mixed salts available.

Estimated Resupply Dates • Mylan has amphetamine mixed salts 5 mg, 7.5 mg, 10 mg, 12.5mg, 15 mg, 20 mg, and 30 mg

immediate release tablets on back order and the company estimates a release date of late-April to early-May 2020.



Carisoprodol Tablets February 12, 2020 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.

Estimated Resupply Dates • Teva has carisoprodol 350 mg tablets in 1,000 count on back order and the company estimates a

release date of late-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=558 Cefazolin Injection February 12, 2020 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 10 gram vials on back order and the company estimates a release

date of late-February 2020. • 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 1 gram and 10 gram vials on allocation. • WG Critical Care has cefazolin 1gram and 10 gram vials on allocation and is shipping product

weekly. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432


Epinephrine Auto-Injectors February 12, 2020 Reason for the Shortage

• Amneal has discontinued Adrenaclick. Amneal acquired Impax in 2018. • Mylan has epinephrine auto-injectors available. • Sandoz launched Symjepi in January 2019 and product is available. • Teva has epinephrine auto-injectors available.

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 Fluvastatin Capsules February 12, 2020 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 mid-February 2020 for the 20 mg capsules and early-March 2020 for the 40 mg capsules.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=561 Hydromorphone Hydrochloride Injection February 12, 2020 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 • Fresenius Kabi has short-dated hydromorphone 2 mg/mL 1 mL vials available with an expiration

date of <7 months. • Hikma has hydromorphone 2 mg/mL 20 mL vials on allocation. • Pfizer has 10 mg/mL 1 mL and 5 mL vials on back order and the company estimates a release

date of May 2020 for the 1 mL vials and February 2020 for the 5 mL vials. The 2 mg/mL 1 mL ampules are on back order and the company estimates a release date of April 2020. The 2 mg/mL 1 mL vials are on allocation. The 4 mg/mL 1 mL ampules are on back order and the company estimates a release date of January 2021. The 1 mg/mL 1 mL iSecure syringes and 2 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of December 2021. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of May 2020.



Lorazepam Tablets February 12, 2020 Reason for the Shortage

• Aurobindo refuses to provide availability information. • Leading has lorazepam tablet presentations available. • Major has lorazepam tablets on shortage due to increased demand. • Mylan has discontinued all bottled presentations. • Mylan Institutional discontinued all unit-dose blister pack presentations. • Sandoz discontinued all lorazepam presentations. • Teva has lorazepam tablets available.

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

release date. • Major has lorazepam 0.5 mg tablets in 100 count bottles on allocation. The company estimates

additional product will be available in mid-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=480 Losartan and Hydrochlorothiazide Tablets February 12, 2020 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 did not provide a reason for the Hyzaar shortage. • Rising discontinued all losartan and hydrochlorothiazide presentations. • 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.

• Sandoz has losartan and hydrochlorothiazide tablet presentations on back order and the company cannot estimate a release date.

• Teva has all losartan and hydrochlorothiazide tablet presentations on back order and the company estimates release dates in mid- to late-February 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=529 Mineral Oil and Petrolatum Ophthalmic Ointment February 12, 2020 Reason for the Shortage

• Allergan did not provide a reason for the shortage. The Lacri-Lube SOP 7 gram tubes have been discontinued.

• Bausch Health has Soothe Night Time ointment available. • Major has Lubrifresh PM available. • 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 in 3.5 gram tubes on back order and the company estimates a

release date in mid- to late-February 2020. • Allergan has Refresh PM in 3.5 gram tubes on back order and the company estimates a release

date in mid-February 2020. Refresh Lacrilube in 3.5 gram tubes is also on back order and the company estimates a release date in early-March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435 Mycophenolate Mofetil Capsules and Tablets February 12, 2020 Reason for the Shortage

• Accord has mycophenolate capsules and tablets available. • Ascend 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. • Genentech has Cellcept available. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • Ascend has all mycophenolate mofetil presentations on intermittent back order and the

company is releasing product as it becomes available. • Hikma has mycophenolate mofetil 250 mg capsules in 100 count and 500 count and 500 mg

tablets in 100 count and 500 count on allocation. • Mylan has mycophenolate mofetil 500 mg capsules in 100 count bottles on back order, and the

company estimates a release date of mid-February 2020. • Sandoz has mycophenolate mofetil 250 mg capsules in 1,440 count 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=448


Nizatidine Capsules February 12, 2020 Reason for the Shortage

• Glenmark did not provide a reason for the shortage. • Mylan discontinued nizatidine capsules. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Glenmark has nizatidine capsules on back order and the company cannot estimate a release

date. • Teva has nizatidine capsules on back order and the company estimates a release date of late-

March 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=634 Promethazine Injection February 12, 2020 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • X-Gen has promethazine injection available.

Estimated Resupply Dates • Hikma has promethazine 50 mg/mL 1 mL ampules on allocation. • Hikma has Phenergan 50 mg/mL 1 mL ampules on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=460 Sodium Bicarbonate Injection February 12, 2020 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. The Neut vials

were discontinued in December 2019. • Fresenius Kabi has sodium bicarbonate on shortage due to increased demand.

Estimated Resupply Dates • Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation. • Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company

estimates a release date of mid-February 2020. • Pfizer has 4.2% sodium bicarbonate 10 mL syringes available in limited supply. The 7.5% 50 mL

syringes are on back order and the company estimates a release date of November 2020. The 8.4% sodium bicarbonate 10 mL syringes are available in limited supply. The 8.4% sodium bicarbonate 50 mL LifeShield syringes are available in limited supply.



Tramadol Tablets February 12, 2020 Reason for the Shortage

• Amneal has tramadol tablets available. • Major has tramadol tablets available. • Mylan has tramadol tablets available. • Sun did not provide a reason for the shortage. • Virtus did not provide a reason for the shortage. • Zydus has tramadol tablets available.

Estimated Resupply Dates • Sun has tramadol 50 mg tablets in 100, 500, and 1000 count bottles on back order and the

company estimates a release date of early-February 2020. • Teva has tramadol 50 mg tablets in 500 count bottles on back order and the company estimates

a release date of early-March 2020. • Virtus has tramadol 50 mg tablets in 500 count bottles on back order and the company

estimates a release date of late-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=628 Verapamil Extended-Release Tablets February 12, 2020 Reason for the Shortage

• Glenmark has verapamil extended-release tablets available. • Mylan did not provide a reason for the shortage. Mylan discontinued their unit dose

presentations in 2019. • Pfizer has Calan SR tablets available.

Estimated Resupply Dates • Mylan has verapamil extended-release tablets on back order and the company estimates a

release date in late-April to early-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=555 Anagrelide Hydrochloride Capsules February 14, 2020 Reason for the Shortage

• Shire (Takeda) did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Torrent has discontinued anagrelide 1 mg capsules. Torrent is working on relaunching

anagrelide 0.5 mg capsules. Estimated Resupply Dates

• Takeda has Agrylin 0.5 mg capsules on allocation. • Teva has anagrelide 0.5 mg and 1 mg capsules on back order and the company estimates a

release date of late-March 2020. • Torrent has anagrelide 0.5 mg and 1 mg capsules on allocation.



Fludarabine Injection February 14, 2020 Reason for the Shortage

• Fresenius Kabi has fludarabine available. • Leucadia has fludarabine available. • Pfizer is discontinuing fludarabine in August 2020. Their estimated market share was less than

1%. • Sagent has fludarabine on shortage due to manufacturing delays. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Pfizer has fludarabine lyophilized powder 50 mg vials available on allocation until supply is

exhausted. • Sagent has fludarabine 25 mg/mL 2 mL vials on allocation. • Teva has fludarabine back order and the company estimates a release date of Q3 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=622 Hepatitis B Vaccine (Recombinant) February 14, 2020 Reason for the Shortage

• Merck has Recombivax HB on shortage due to increase in global demand. • GlaxoSmithKline has Engerix B products available. • GlaxoSmithKline discontinued Engerix B pediatric vials in October 2017.

Estimated Resupply Dates • Merck has Recombivax HB adult formulation vials and syringes on back order and the company

estimates this will continue through 2020. • Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent

formulation vials in limited supply and this will continue through mid-2020. Merck's limited supply is being allocated to the CDC to ensure use is in accordance with their clinical guidance.

• Merck has Recombivax HB dialysis formulation 40 mcg/mL on back order and the company estimates this will continue through 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=320 Irbesartan Tablets February 14, 2020 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.

• Solco and ScieGen were affected by the recall. • Camber, Lupin, and Westminster did not provide a reason for the shortage. • Hikma is not actively marketing irbesartan tablets. • MacLeod's has irbesartan tablets available to contracted customers only. • Sanofi-Aventis has Avapro tablets available.


• Repackagers may have some presentations affected depending on the source supplier. Estimated Resupply Dates

• Alembic has irbesartan 75 mg tablets in 30-count bottles and 300 mg tablets in 90- and 500-count bottles on back order and the company cannot estimate a release date. All other tablet presentations are on intermittent back order and the company is releasing drug as it becomes available.

• Camber has irbesartan tablets on allocation. • Lupin has irbesartan tablets on allocation. • Solco has irbesartan tablets on long-term back order and the company cannot estimate a

release date. • Westminster has irbesartan 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=580 Lorazepam Injection February 14, 2020 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 • Hikma has lorazepam 2 mg/mL 1 mL vials on back order and the company estimates a release

date of mid-February 2020. • Hikma has Ativan 2 mg/mL 1 mL vials on back order and the company estimates a release date

of mid-February 2020. • Pfizer has lorazepam 4 mg/mL 1 mL Carpuject syringes on back order and the company

estimates a release date of January 2021. The 2 mg/mL 10 mL vials are on back order and the company estimates a release date of August 2020; however, there are short-dated 2 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=87 Loxapine Tablets February 14, 2020 Reason for the Shortage

• TEVA has loxapine tablets on shortage and did not provide a reason. The company discontinued loxapine 10 mg tablets in September 2019.

• Marlex has loxapine tablets on shortage and did not provide a reason. • Lannett has loxapine tablets on shortage due to manufacturing delays. • Mylan Institutional has loxapine tablets on shortage and did not provide a reason.



• Lannett has loxapine 5 mg, 10 mg , and 50 mg tablets on back order and the company estimates a release date of late-February 2020 for the 5 mg tablets and late-February to early-March 2020 for the 10 mg and 50 mg tablets.

• Marlex has loxapine 5 mg, 10 mg, 25 mg, and 50 mg tablets on back order and the company cannot estimate a release date.

• Mylan Institutional has loxapine 5 mg, 10 mg, 25 mg, and 50 mg tablets on back order and the company estimates a release date of late-April 2020.

• Teva has loxapine 5 mg tablets on back order and the company estimates a release date of late-January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=593 Mepivacaine Injection February 14, 2020 Reason for the Shortage

• Fresenius Kabi has Polocaine available. • Pfizer states the reason for the shortage is manufacturing delays.

Estimated Resupply Dates • Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose

vials, 1% Carbocaine 30 mL preservative-free vials and 50 mL multiple-dose vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Prednisone Oral Tablets February 14, 2020 Reason for the Shortage

• Cadista, Hikma, and Par did not provide a reason for the shortage. • Teva has prednisone tablets on shortage due to manufacturing delays.

Estimated Resupply Dates • Cadista has all prednisone tablet presentations available. Cadista recently discontinued the 10

mg tablets in 500 count bottles and the 20 mg tablets in 1000 count bottles. • Hikma has 2.5 mg tablets in 100 count available. All other prednisone tablet presentations are

on allocation. • Par has predisone 5 mg tablets in 21- and 48-count blister packs and 100 count bottles, and 10

mg tablets in 48 count blister packs on back order and the company cannot estimate a release date.

• Teva has prednisone 5 mg tablets in 48-count blister packs and 10 mg tablets in 21-count blister packs on back order and the company estimates a release date of mid-February 2020. The 5 mg tablets in 1,000 count bottles, the 10 mg tablets in 48-count blister packs, and the 20 mg tablets in 100-count bottles are on back order and the company estimates a release date of late-February 2020. The 10 mg tablets in 1,000-count bottles are on back order and the company estimates a release date of early-March 2020.



14.6% Sodium Chloride Concentrated Solution for Injection February 18, 2020 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 February 2023. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=416 23.4% Sodium Chloride Injection February 18, 2020 Reason for the Shortage

• Fresenius Kabi has 23.4% sodium chloride injection available. • Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.

Estimated Resupply Dates • Pfizer has 23.4% sodium chloride 100 mL vials on back order and the company estimates a

release date of April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 5% Dextrose Injection (PVC-free and DEHP-free) February 18, 2020 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 did not provide a reason for the shortage. • ICU Medical had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has 5% dextrose in 500 mL PVC/DEHP-free bags available with short expiration

dating (< 3 months). • ICU Medical has 5% dextrose in 50 mL PVC/DEHP-free bags 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=314 Acyclovir Injection February 18, 2020 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Fresenius Kabi had acyclovir injection on shortage due to increased demand.

Estimated Resupply Dates • AuroMedics has acyclovir 50 mg/mL 10 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=590


Argatroban Injection February 18, 2020 Reason for the Shortage

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

Estimated Resupply Dates • Fresenius Kabi has argatroban 100 mg/mL 2.5 mL vials on back order and the company

estimates a release date in early-March 2020. • Mylan has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a

release date in mid-April 2020. • Teva has argatroban 1 mg/mL 250 mL vials in packs of 5 on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=494 Calcium Chloride Injection February 18, 2020 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 May 2020. The 100 mg/mL 10 mL LifeShield syringes are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 Cefoxitin Sodium Injection February 18, 2020 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 2 gram vials on back order and the company estimates a release

date of mid-June 2020. • Hikma has cefoxitin 1 gram and 10 gram vials on back order and the company estimates a

release date late-June to early-July 2020. The 2 gram vials are on allocation. • Sagent has cefoxitin 2 gram and 10 gram vials on back order and the company estimates a

release date of April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Chlordiazepoxide Capsules February 18, 2020 Reason for the Shortage

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

Estimated Resupply Dates • Mylan Institutional has chlordiazepoxide 5 mg capsules in 100 count unit-dose packs on back

order and the company estimates a release date of mid- to late-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=612 Dexamethasone Sodium Phosphate Injection February 18, 2020 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 had dexamethasone injection on shortage due to increased demand. • Somerset Therapeutics has 10 mg/mL 1 mL and 10 mL vials available.

Estimated Resupply Dates • AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL vials on intermittent back

order and the company is releasing product as it becomes available. • Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL vials on allocation. The 10 mg/mL

1 mL vials are on back order and the company estimates a release date of late-February 2020. • Fresenius Kabi has dexamethasone sodium phosphate 4 mg/mL 5 mL and 30 mL vials on back

order and the company estimates a release date of late-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140


Enalaprilat Injection February 18, 2020 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 2 mL vials on allocation. • Pfizer has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials 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=488 Enoxaparin Sodium Injection February 18, 2020 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 has enoxaparin available. • Winthrop has enoxaparin available.

Estimated Resupply Dates • Fresenius Kabi has enoxaparin 120 mg/80 mL 0.8 mL prefilled syringes available with short

expiration dating (< 7 months). • Sanofi-Aventis has Lovenox 150 mg/mL 1 mL and 30 mg/0.3 mL prefilled syringes 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 Fentanyl Citrate Injection February 18, 2020 Reason for the Shortage

• Akorn has fentanyl injection available. • 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 20 mL vials on back order and the company estimates a

release date of early-April 2020. • Hikma has fentanyl 50 mcg/mL 5 mL vials available with an expiration date of November 2020. • Pfizer has fentanyl 50 mcg/mL 10 mL and 20 mL vials on back order and the company estimates

a release date of February 2020. The 2 mL and 50 mL vials are available in limited supply. The 2


mL Carpuject syringes are on back order and the company estimates a release date of January 2023.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Leucovorin Calcium Injection February 18, 2020 Reason for the Shortage

• Fresenius Kabi has 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 500 mg vials on back order and the company estimates a release

date of mid-February 2020. The 10 mg/mL 50 mL vials are short-dated with < 2 months expiration dating.

• Hikma has leucovorin 50 mg, 100 mg, 200 mg, and 350 mg vials on back order and the company estimates a release date of late-February 2020.

• Sagent has leucovorin 50 mg, 100 mg, 200 mg, 350 mg, and 500 mg vials on back order and the company estimates a release date of December 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Lidocaine Injection February 18, 2020 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 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of late-February 2020. Check wholesalers for inventory.

• Hikma has 1% lidocaine 5 mL vials on back order and the company estimates a release date of mid-February 2020.

• Pfizer has 0.5% lidocaine 50 mL tear drop vials and 50 mL flip top vials on back order and the company estimates a release date of February 2020. The 1% lidocaine 5 mL preservative-free ampules are on back order and the company estimates a release date of March 2020. 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 available in limited supply. The 2% lidocaine 5 mL vials are available in limited supply.The 2% lidocaine 5 mL LifeShield syringes are available in limited supply. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of April 2020.



Lidocaine with Epinephrine Injection February 18, 2020 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) 20 mL vials are on back order and the company estimates release dates of late-February 2020. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of late-February 2020. The 1% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of early-March 2020. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of mid-March 2020. 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-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of late-February 2020. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials are on back order and the company cannot estimate a release date. 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 short-dated 1% lidocaine with epinephrine (1:100,000) 30 mL vials available with an expiration date of May 2020. The 1.5% lidocaine with epinephrine (1:200,000) 30 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 February 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Magnesium Sulfate Injection February 18, 2020 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 early- to mid-March 2020. The 1,000 mL premixed bags are on back order and the company estimates a release date of late-February 2020. The 40 mg/mL 100 mL premixed bags are on back order and the company cannot estimate a release date. The


500 mg/mL 20 mL vials are on back order and the company estimates a release date of early-March 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 premixed bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Methotrexate Injection February 18, 2020 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 has methotrexate injection available. • Teva has methotrexate injection available. • Hikma has methotrexate injection available.

Estimated Resupply Dates • Hikma has methotrexate 1 gram vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Oxytocin Injection February 18, 2020 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Par has Pitocin available.

Estimated Resupply Dates • Fresenius Kabi has oxytocin 10 unit/mL 30 mL vials on back order and the company estimates a

release date of mid- to late-February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=608 Prednisolone Oral Solution February 18, 2020 Reason for the Shortage

• Akorn did not provide a reason for the shortage. • Pharmaceutical Associates Inc. has prednisolone oral solution available. • Seton Pharmaceuticals has prednisolone oral solution available.

Estimated Resupply Dates • Akorn has prednisolone 3 mg/mL in 120 mL, 240 mL, and 480 mL bottles on back order and the

company estimates release dates in February 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=620


Ropivacaine Injection February 18, 2020 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 ropivcaine 10 mg/mL 10 mL vials and 2 mg/mL 100 mL bottles on intermittent

back order and the company is releasing product as it becomes available. There is a limited supply of short-dated 10 mg/mL 10 mL vials 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 100 mL bottles are on back order and the company estimates a release date of mid-March 2020. The 2 mg/mL 200 mL bottles are on back order and the company estimates a release date of early- to mid-March 2020.

• Pfizer has short-dated ropivacaine 7.5 mg/mL 20 mL vials available with an expiration date of April 2020. There are short-dated 10 mg/mL 10 mL vials available with an expiration date of June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Simethicone Oral Liquid February 18, 2020 Reason for the Shortage

• Geri-Care did not provide a reason for the shortage. • GSK Consumer Healthcare discontinued Baby Gas-X simethicone oral solution. • Major did not provide a reason for the shortage. • Perrigo has simethicone oral suspension available. • Rugby did not provide a reason for the shortage.

Estimated Resupply Dates • Geri-Care has simethicone 20 mg/0.3 mL oral suspension in 30 mL bottles on back order and the

company estimates a release date of early- to mid-March 2020. • Major has simethicone 20 mg/0.3 mL oral suspension in 30 mL bottles on back order and the

company cannot estimate a release date. • Rugby has simethicone 20 mg/0.3 mL oral suspension in 30 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=632 Sulfasalazine Enteric-Coated and Immediate-Release Tablets February 18, 2020 Reason for the Shortage

• Greenstone did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Pfizer has sulfasalazine available.


Estimated Resupply Dates • Greenstone has sulfasalazine enteric-coated 500 mg tablets in 100 and 300 count bottles on

back order and the company estimates a release date of mid-March 2020 for the 100 count and late-March 2020 for the 300 count bottles. The immediate-release 500 mg tablets in 100 and 300 count bottles are on back order and the company estimates a release date of late-February 2020 for the 100 count and late-March 2020 for the 300 count bottles.

• Teva has sulfasalazine immediate-release 500 mg tablets in 100, 500, and 1000 count bottles on back order and the company estimates a release date of early-March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=625 Temazepam Capsules February 18, 2020 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 did not provide a reason for the shortage. • 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 late-April to early-May 2020. • Teva has temazepam 15 mg in 100 and 500 count and 30 mg in 500 count 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=503 Testosterone Cypionate Injection February 18, 2020 Reason for the Shortage

• Cipla has testosterone cypionate injection on back order because the company is changing NDC numbers.

• Hikma and Perrigo did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortage of Depo-Testosterone. • Sun Pharma has testosterone cypionate injection available.

Estimated Resupply Dates • Cipla has testosterone cypionate injection on back order and the company cannot estimate a

release date. • Hikma has testosterone cypionate 200 mg/mL 1 mL and 10 mL vials on allocation. • Perrigo has testosterone cypionate 200 mg/mL 10 mL vials on back order and the company

estimates a release date of early-March 2020. • Pfizer has testosterone cypionate 200 mg/mL 1 mL vials available in limited supply. • Sun has testosterone cypionate 200 mg/mL 1 mL and 10 mL vials, and 100 mg/mL 10 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=592 Venlafaxine Hydrochloride Extended-Release Capsules February 18, 2020 Reason for the Shortage

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

presentations. Estimated Resupply Dates

• Teva has most venlafaxine extended-release capsules on back order and the company estimates a release date in late-February 2020.

• Zydus has all venlafaxine extended-release capsules on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=587 Bupivacaine with Epinephrine Injection February 19, 2020 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-March 2020. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of late-February 2020. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of early- to mid-March 2020. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of early-March 2020. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of early- to mid-March 2020. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of early- to mid-March 2020. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date. There are short-dated 0.75% Sensorcaine with epinephrine 30 mL vials with an expiration date of <5 months.

• Pfizer has 0.25% bupivacaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of June 2021. The 0.25% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021.

• Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of June 2021. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June


2021. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of June 2021. 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 June 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Methadone Injection February 18, 2020 Reason for the Shortage

• Akorn has methadone injection on back order due to delayed batch releases. • Mylan did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has methadone injection on back order and the company estimates a release date of late-

March to early-April 2020. • Mylan has methadone injection on back order and the company estimates a release date of

mid-April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=635 *Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

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Drug Information Update...Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 m g Tablets, Lot # 331771 (expiration