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RECALL PROCEDURES 06/07/22 1

Recall procedures

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Page 1: Recall procedures

RECALL PROCEDUR

ES

04/10/23 1

Page 2: Recall procedures

TABLE OF CONTENTS:I. Recall Page # 3

II. FDA responsibilities Page # 4i. Responsibilities of OE/DCMO Page # 5

ii. Responsibilities & procedures - OE/DCP Page # 6

iii. Responsibilities & procedures – OE/DCIQA Page #6

III. Recall Enterprise System (RES) Page # 7

IV. Center Recall Unit (CRU) Page # 8

V. Health Hazard Evaluation (HHE) Page # 9

VI. Recall Initiation Page # 10

VII. Recall Classification Page # 11i. Class I Recall Page # 12

ii. Class II Recall Page # 13

iii. Class III Recall Page # 14

VIII. Alerting the public Page # 15

IX. Monitoring Recall Effectiveness Page # 16

X. Termination of Recall Page # 17-18

XI. Responsibilities of Recalling Firm Page # 19i. Preparing of the Recall Page # 20

ii. Determining the Scope of the Recall Page # 21

iii. Determining the Depth of the Recall Page # 22

iv. Communicating with FDA Page # 23

v. Communicating with Consignees Page # 25

vi. Press release Page # 25

XII. Drug Recalls in 2013. Page # 26-28

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Page 3: Recall procedures

RECALL• Recall means a firm’s removal or correction of a

marketed product(s) that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.

OR

• Recalls are an alternative appropriate method of removing or correcting marketed consumer products, their labeling, and/or promotional literature that violates the laws administered by FDA.

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Page 4: Recall procedures

FDA RESPONSIBILITIES• FDA is involved in recall procedures.

• Monitor the recall by reviewing firm’s status reports and conducting audit checks (District)

• Discuss and approve recall strategy –including press releases (District/Center -Office of Public Affairs for press)

• Classify the recall (Center)

• Terminate the recall (District Class II and III; Center approval for class I)

• FDA will take appropriate regulatory action or other measures when the firm fails to recall violative product or when a recall action fails.

• These actions will be taken in consultation and coordination with the district compliance branch, the appropriate center recall and compliance staffs, OE/DCMO and when indicated, the officer of Chief Counsel, when:

– A firm refuses to recall or sub-recall after being requested to do so by FDA;

– A firm fails to complete recall in a timely fashion;

– The agency has reason to believe that a recall strategy is not effective.

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Page 5: Recall procedures

• Responsibility of Office of Enforcement / Division of Compliance Management and Operations

–OE/ DCMO is the agency’s headquarters contact and focal point for information, advice, and direction for field recall operations and remains involve with each recall throughout its process.–If required, it may direct appropriate follow up actions by the field.–It periodically reviews all agency recall activities to ensure that current policy & procedures are being applied to recalls and recommends changes are appropriate.–It informs OE/DCIQA of recalls that may affect govt. agencies.–It evaluates the overall effectiveness of recall activities.–It communicates trends, common cause of recalls, control weakness, etc., having the needs for this information.

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Page 6: Recall procedures

• Responsibilities & Procedures - Office of Enforcement/ Division of Compliance Policy

–OE/DCP reviews and resolves compliance policy issues related to recalls. –The division reviews recall action memorandums when requested by OE/DCMO.–OE/DCP provides written response to OE/DCMO.

• Responsibilities & Procedures - Office of Enforcement/Division of Compliance information & Quality Assurance

–OE/DCIQA receives recall information from OE/DCMO when the identified consignees include government agencies.–It forwards the information, as appropriate, to the applicable government agencies.

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Page 7: Recall procedures

RECALL ENTERPRISE SYSTEM• The Recall Enterprise System (RES)is an electronic data system used by FDA

recall personnel to submit, update, classify, & terminate recalls.

• The RES increases efficiency in processing recall information by:

– Allowing field coordinators to input recall information via on-line, internet system;

– Allowing users to build a record of the entire recall by entering information as it becomes available thus reducing preparation time and providing consistency throughout the agency;

– Reducing duplication of efforts between the Field officer, OE, the centers, and Office of public affairs;

– Increasing communication of recall information between field, headquarters and the appropriate center(s) office;

– Using a uniform Health Hazard Evaluation (HHE) form or a form equivalent to HHE form to promote consistency in evaluating potential health hazards;

– Providing the public with “real-time” information about the FDA recall process.

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Page 8: Recall procedures

CENTER RECALL UNIT(CRU)

• The Center recall unit:1. Initiates a health hazard evaluation (HHE)2. Finalizes a recall strategy3. Classifies the recall and, for Class I recalls,

prepares an Action memorandum for Center Director or his/her designee concurrence before forwarding it to OE/DCMO and the ACRA; and,

4. Updates RES with classification, audit strategy, and any recommendations, and posts the information to the internet.

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Page 9: Recall procedures

HEALTH HAZARD EVALUATION

•Diseases or injuries which have already occurred

•Existing conditions that can contribute to a clinical condition

•Population

•Seriousness of hazard

•Likelihood of occurrence of hazard

•Immediate and long term consequences

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Page 10: Recall procedures

RECALL INITIATION• Recall may initiated in three ways:

1. Firm initiated Recalls: A manufacturer or distributor may voluntarily initiate a recall at any time.

2. FDA requested Recalls: Under certain urgent situations, FDA may request that a manufacturer or distributor recall a product.

3. FDA Ordered Recalls: Under certain authorities, FDA may mandate a recall. It includes:– Mandatory Device recalls– Mandatory of biological products– Mandatory recall of human tissue intended for transplantation– Infant formula– Interstate milk shipments– Tobacco products

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Page 11: Recall procedures

RECALL CLASSIFICATION

• Numerical designation (i.e., I, II, or III) is assigned by FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

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Page 12: Recall procedures

• CLASS I RECALLS

Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Examples of Class I Recalls

•Pathogens in ready-to-eat food: Salmonella, Listeria monocytogenes, E. coli, Clostridium

•High levels of sulfites

•High levels of heavy metals

•Choking hazards for susceptible populations

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Page 13: Recall procedures

• CLASS II RECALLS

Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Examples of Class II Recalls

•Foreign objects that pose a physical hazard

•Pathogens: Shigella, hepatitis A, Cyclospora, Cryptosporidium

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Page 14: Recall procedures

• CLASS III RECALLS

Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

• Example of Class III Recalls

An example might be bottles of aspirin that contains 90 tablets instead of the 100 stated on the label.

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Page 15: Recall procedures

ALERTING THE PUBLIC• FDA seeks publicity about a recall only when it believes the public needs

to be alerted to a serious hazard.

• When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people.

• FDA can hold press conferences, issue press releases, and post updates to its Web site regularly, to alert people.

• Not all recalls are announced in the media. But all recalls go into FDA's weekly Enforcement Report. This document lists each recall according to classification, with the specific action taken by the recalling firm.

• "It's about being as transparent as possible," says Catherine McDermott, public affairs manager in the Division of Federal-State Relations in FDA's Office of Regulatory Affairs. "If we feel there is that much of a health risk, we will offer media updates every day to give new information, and all that we know gets posted to FDA's Web site."

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Page 16: Recall procedures

MONITORING RECALL EFFECTIVENESS

• FDA evaluates whether all reasonable efforts have been made to remove or correct a product.

• A recall is considered complete after all of the company's corrective actions are reviewed by FDA and deemed appropriate.

• After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place

• A recalling firm may be unable to check the effectiveness of its recall when a recall extends to the consumer-user level, the confidential business record of a firm’s customers are not accessible, wholesalers, distributors or retailors do not cooperate, or because an urgency of the situation requires an all-out effort.

• In such cases, when a recalling firm unable to check its effectiveness, FDA will directly assist in this activity and, where necessary, seek assistance from cooperating state and local agencies.

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Page 17: Recall procedures

TERMINATION OF RECALL• FDA will terminate a recall when the monitoring district office

determines that the recalling firm has completed all recall activity, including monitoring and final product disposition.

• The district will notify the recalling firm by a letter that FDA considers the recall terminated.

• Termination of Class I recall and a Safety Alert requires center concurrence. When the monitoring district concludes that such a recall and a Safety Alert has been completed, the district recall coordinator will enter the information required for termination in RES on the “Summary & Termination “ page then verify the information then send an email to the CRU recommending termination.

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Page 18: Recall procedures

• Upon receipt of the termination recommendation email, the CRU will access RES, review the termination information and change the “recall status” field to “terminated” and generates an email to the district and OE/DCMO advising that the recall is terminated

• Center approval is not required for Class II and III recall terminations.

• As a rule FDA should terminate the recall within three months after the firm completes the recall.

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Page 19: Recall procedures

RESPONSIBILTIES OF RECALLING FIRM

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Page 20: Recall procedures

Preparing for a recall

• Review available recall guidance

• Develop a recall plan

• Maintain manufacturing and distribution records in a manner to facilitate a timely and effective recall

• Identify finished products with a lot number/code

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Determining the scope of the recall.

•When did the problem start/end?

•Can additional lots/products be affected other than the lot/product analyzed and found adulterated?

•How many sizes/labels for the product?

•Is the product coded with a lot number?

•Shelf life of product

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Page 22: Recall procedures

Determining the depth of the recall

•Class I recalls generally to consumer/user depth via press release

•Class II generally to retail depth; some to consumer/user via press release

•Class III generally to retail depth when problem when problem obvious to consumer

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Page 23: Recall procedures

Communicating with the FDA• Notify FDA District Recall Coordinator and provide information in a timely manner

• Info needed by FDA includes: – Product (identity, size and type of containers, brand names, lot numbers, whether refrigerated/frozen/shelf stable)

– Codes

– Amount manufactured and amount distributed

– Number of and types of consignees

– Area of distribution

– Reason for recall

• Discuss recall strategy with FDA (including disposition of recalled product)

• Let FDA review text of phone notifications, written recall notifications, press releases (follow models provided in FDA guidance)

• Provide FDA with consignee list

• Provide actual labels or clear photos of labels

Cont...04/10/23 23

Page 24: Recall procedures

Communicating with Consignees

•Be brief and to the point

•Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product

•Explain concisely the reason for the recall and the hazard involved, if any

•Provide specific instructions on what should be done with respect to the recalled products

•Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product

•Provide sub-recall instructions (if necessary)

•Re-contact non-responders and conduct effectiveness checks04/10/23 24

Page 25: Recall procedures

Press release

•Follow FDA models as closely as possible –“fill in the blanks”

•Do not change hazard statement –don’t take out “life threatening”

•Issue press release to Associated Press

•Provide FDA with confirmation that press release was sent to AP

•FDA will issue if firm will not or if firm’s is inadequate

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Page 26: Recall procedures

DRUG RECALLS in 2013

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Page 27: Recall procedures

drugs recall in 2013Date Brand Name Product Description Reason/ Problem Company

07/03/2013 Estarylla

Estarylla (norgestimate and ethinyl estradiol)

tablets

Report of a placebo tablet

present in a row of active tablets

Sandoz

06/30/2013 Nexus, APP Benztropine

Mesylate Injection Glass particles Fresenius Kabi USA

06/19/2013 Rugby Enteric Coated

Aspirin Tablets,81 mg

May Contain Acetaminophen 500 mg tablets

Advance Pharmaceutical Inc.

06/13/2013Sagent Pharmaceuticals, Inc.

Vecuronium Bromide for

Injection

Due to elevated impurity levels

Sagent Pharmaceuticals, Inc.

06/11/2013 Bethel Weight Loss Pills Contains

Undeclared Drug Ingredient

Bethel Nutritional Consulting, Inc.

06/10/2013 ZyGenerics Warfarin 2 mg

Tablets Oversized tablet

Zydus Pharmaceuticals

USA Inc.

06/07/2013Sagent Pharmaceuticals,

Inc.

Vecuronium Bromide for

Injection

Due to elevated impurity levels

Sagent Pharmaceuticals, Inc.

04/10/23 27http://www.fda.gov/Safety/Recalls/default.htmhttp://www.fda.gov/Safety/Recalls/default.htm

Page 28: Recall procedures

04/10/23 28

Date Brand name Product Description

Problem/Reason Company

05/29/2013Lowlite, Olympia

Pharmacy All Sterile Products

Potential for non-sterility

Lowlite Investments, Olympia Pharmacy

05/28/2013Main Street Family

Pharmacy All Sterile Products

Potential for non-sterility

Main Street Family Pharmacy, LLC

05/25/2013 Fresenius Kabi USA Magnesium Sulfate

Injection USP Glass Particles Fresenius Kabi USA

05/21/2013JaDera, Xiyouji

Qingzhi Weight loss supplement

Unapproved New Drug

Dolphin Intertrade Corp

05/20/2013 Sandoz

Methotrexate Sodium, USP, 25

mg/mL, 40 mL vial injectable vials

Particulate material in vials

Sandoz US

05/15/2013 Pentec Health In-date nutritional prescriptions for renal patients

Lack of sterility assurance

Pentec Health

05/10/2013 Hospira Piperacillin and Tazobactam for

Injection

Precipitation/Crystallization in

IV bagApotex Corp.

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