How to Effectively Manage a Product Recall - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

How to Effectively Manage a Product Recall
The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.

Pharmaceutical Technology
Volume 35, Issue 1

Not too many words in the English language cause heads to turn and skin to crawl like the word recall. Product recalls are situations that all companies try their best to avoid, but if a recall is necessary, how does a company effectively develop and implement a plan without undue delay and confusion?

The actions to consider when conducting a product recall can be grouped into seven areas. Each of these areas should be executed carefully and thoroughly in order to effectively manage the recall activity. This article discusses the following seven recall areas: conducting a health-hazard assessment, planning a course of action, contacting the US Food and Drug Administration, getting the word out, the importance of keeping accurate records, staying focused, and when is the recall actually ended?

What is a recall and when is it necessary?

To effectively manage a product recall, it is important to first understand what constitutes a recall and when it is necessary. Simply put, a recall is necessary when a product is found to be defective in some way, and removing it from the market is the only way to ensure consumer safety. Recalls can be either voluntary (i.e., undertaken by the manufacturer or distributor at any time) or can be initiated at the request of FDA (usually reserved for urgent and serious situations).

A recall usually results from one or a combination of the following situations:

1. Company discovery: A company discovers, through its own routine testing program, that a product lot does not meet one or more of the specifications that are established for that product.

2. Customer complaint: Often a problem is discovered from customer complaints.

3. FDA observation: Recalls can also be necessitated as a result of an observation made by FDA during an inspection. Significant compliance deficiencies noted by FDA can result in a company having to recall some or all of its drug lots.

Conducting a health-hazard assessment

Table I: Health-hazard assessment elements.
Not all product failures that are discovered by a company lead to a recall. To determine whether a recall may be necessary, the impact that the failure may have on the safety and efficacy of the product must be evaluated. This is done by conducting a health-hazard assessment. By performing and documenting the hazard-assessment, conclusions can be drawn as to the chance that a consumer can be harmed by using the product in question. Often, companies use product experts to consult in the assessment. The type of expert will depend on the nature of the product, (e.g., medical doctors, pharmacologists, and toxicologists). A summary of the basic elements that should be included in a health-hazard assessment are listed in Table I. If the overall conclusion is that there are or may be harmful effects from the failure, a recall will be necessary and removing the product from the marketplace becomes the top priority.

Table II: Example of a health-hazard assessment.
An example of a situation when a recall was determined to be unnecessary was observed in a solid oral-dosage form plant. Table II shows an example of the health-hazard assessment that was conducted and how the ultimate conclusion was reached.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here