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
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 I: Health-hazard assessment elements.
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.
Table II: Example of a health-hazard assessment.