On Recalls

National Archives:  Pharmacist preparing a prescription (ca 1943)

Some of the following information has been abstracted from our reprint, When Things Go Wrong, Part I:  The Consequences of Noncompliance.This article originally appeared in BioPharm Magazine in August 2000, with perrmission to reprint given by Advanstar Communications. Other sources for the following information: FDA Enforcement Story, FDA Regulatory Procedures Manual, Chapter 7, Recalls, and the FDA Enforcement Report Index, U.S. Food and Drug Administration, Rockville, MD, and personal conversation with Maureen O’Connor, retired QA executive and former Director of Corporate Quality Assurance for Syntex Corporation.)

On Recalls

The following information is not intended to be all-inclusive.  Please consult with your company’s quality assurance and/or regulatory compliance executive, as well as review the specific regulatory requirements for handling a recall in the Code of Federal Regulations, 21 CFR 7.

One of the trends that we have been watching with some concern is that the total number of industry recalls has more than quadrupled in the last 14 years, from 1,162 recalls in 1991 to 5,338 recalls in 2005. These figures include recalls of all types of FDA-regulated products: human drugs, biologics and medical devices, blood or blood products, animal drugs and feed, and food and cosmetics. While most companies will voluntarily recall a product when they discover, despite their best efforts, that they have shipped nonconforming product, most recalls reflect a breakdown in a manufacturer's quality system.

FDA has the authority to order mandatory medical device recalls and corrections and removals, mandatory recalls of biological products, mandatory recalls of human tissue intended for transplantation (bone, ligaments, tendons, cartilage, skin, fascia, and corneas), infant formula recalls, and recalls of interstate milk shipments. That being said, it has been our experience that most companies will voluntarily recall a product, including if FDA asks them to recall it. Recalls that have been reported to FDA, and classified by them, are published in the biweekly FDA Enforcement Report.

FDA has an excellent recall guidance, Guidance for Industry: Product Recalls, including Corrections and Removals, which is available on line. FDA also maintains a web page containing model letters, model press releases, and effectiveness check information. We highly recommend reviewing your existing recall procedure against the agency's guidance documents for any changes that you wish to incorporate in your own procedure or system. We also highly recommend periodically testing your recall system, at least once a year, to make sure that it works, and contacting FDA and other, appropriate world regulatory agenc(ies) rapidly in the event that you must conduct a recall.

U.S. product recalls fall into one of three classes, the most serious being Class I, or an immediate threat to public health:

          Class I:  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 

          Class II:  A situation in which the 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.

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

Every company should have an SOP on recalls, and should have a system set up to immediately convene a quality advisory team led by Quality Assurance, with representatives from different functions, including manufacturing, compliance, regulatory affairs, clinical and/or medical, legal counsel, public affairs or investor relations, and so on.  That team should be able and willing to meet as rapidly and as often as necessary to identify and/or determine the full scope and severity of the situation, whether additional product(s) are affected, and what additional tests need to be done, such that the QA head may rapidly consult with and notify appropriate regulatory agencies in classifying and handling the recall.  QA must lead to conclusion any situation involving a product recall.  If you are ever faced with a potential recall, the following information, “Recall Meeting:  Some Items to Consider,” may prove useful.

Recall Meeting:  Some Items to Consider

1. Scope of problem

  • Which product?  Indication?
  • How many units or lots?
  • When distributed?
  • Where distributed?
  • Any other products or dosage forms affected?
  • When did you learn of the problem?
  • How did you learn of the problem?
  • Internal discovery or test result?  If yes, give details.
  • External discovery?  If external, give nature and details of original complaint, as well as name, phone number, and address of complainant.
  • Any corrective action taken?
  • Any reply to complainant?
2. Cause of problem
  • If unknown, probable causes
  • How being investigated
  • How soon identify cause?
  • Did product fail to meet its specifications?
  • Is product or device being used for treatment or diagnosis?
  • Relationship, if any, of the product or device to reported incident or adverse event
3. Classification of recall
  • Risk to patient
  • Life threatening?
  • Product indication and patient population
  • Seriousness of defect or recall issue
4. How to do the recall
  • Notify distributors – get confirmation of receipt
  • If life-threatening, get all units back and destroy them, document their 
  • destruction, and ensure traceability of all units
  • If a few units, notify by phone and follow-up by letter
  • Write a script for the phone work, and insist on individuals following the script, so they do not babble
  • If sales reps or technical reps installed the product (such as with a device or instrument system), have them retrieve them
  • Before distribution, have the recall letter first reviewed by legal counsel – letter should tell the recipients the necessary information, but not babble or go on.  Clearly identify the letter as a recall letter.
  • Follow your recall SOP
5. Notify FDA local office (or appropriate world regulatory agencies, if your product is available outside the United States)
  • Product(s)
  • Scope (all lots or units)
  • Cause (If known; if not, working on it)
  • Risk and recommended classification
  • 72 hour field alert needed?  A medical device report (MDR)?  Biological product deviation report (formerly called an errors and accident report)?
  • How you plan to do the recall
  • All products affected
This last point is very important.  You do not want to do one recall, and then turn around a few days or week later, and do another.  That behavior also does not make any regulatory agency feel comfortable about either your state of control or your ability to handle the recall.

Use Information
The information on this page is provided free-of-charge for downloading, photocopying, and using in your classes or department meetings.  The reprinting, transmission, or distribution for sale or use in a for-fee conference or course of this information is expressly prohibited.  If you download the material, please ensure that the following copyright statement appears prominently on the bottom of each page downloaded:

Copyright 2010, Immel Resources LLC, Petaluma, CA USA, (707) 778-7222, immel@immel.com. 
Permission to reprint given by Immel Resources LLC.

This information is not all-inclusive nor is it intended to replace the advice of an experienced quality assurance or regulatory compliance professional.  Every organization manufacturing pharmaceutical, biological, and medical device products must meet at least the minimum, applicable current good manufacturing practices (CGMPs).

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