How to Effectively Manage a Product Recall - Pharmaceutical Technology

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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

Planning a course of action


Table III: Critical recall information list.
When the results of failing tests, product complaints, or compliance deficiencies noted during an inspection determine that a recall is necessary, time is of the essence and decisive action is critical. Communication lines among many different departments should be established. Vital information must be gathered, and a recall strategy needs to be generated. All these steps must be accomplished without delay. The completeness of this information will greatly reduce the effort that will be needed to execute the recall and ultimately remove the product from the marketplace. A list of the critical information that needs to be collected is presented in Table III. This information, along with the health-hazard assessment, will be among the first documents in the recall record and will drive the remaining recall activities.

Once the company has gathered all the necessary information, a recall strategy is established. A recall strategy is essentially the blueprint of the actions that are to be taken to effectively and efficiently remove the product or products in question from the marketplace. This strategy must take into account all the factors that are involved with the recall and all the steps that are necessary to accomplish the desired goal (removing and accounting for all distributed product).

The recall strategy states the suggested depth of the recall. Recall depth is the level in the distribution chain to which the company will contact in order to retrieve the recalled product. There are three levels: wholesale level, retail level, and consumer level. The selected level is determined by the severity and probability of the health hazard associated with the product based upon the conclusions of the health-hazard assessment. Recalls on the wholesale level usually are necessary when the product poses little to no health risk.

The more serious the risk created by the product, the greater the depth of the recall. An example of a recall that may be conducted on the wholesale or retail level are a product with a label that had an inaccurate statement such as a warning for taking more than 8 tablets in 24 hours, when in fact the statement should be 12 tablets in 24 hours. Other examples include a product that, upon shelf life testing, failed to meet the potency specification prior to the stated expiration date or a product that failed a sterility test.

A recall on the consumer level is the most serious type of recall, as the product has a chance to cause serious health risks and even death. In this case, it is critical to remove as much product as possible from the market. An example of a recall that may be conducted to the consumer level is a product that contains an ingredient that may cause harm if taken in the quantities listed.

Besides the recall depth, a recall strategy includes the detailed plan for executing the recall, including how to communicate the recall and how the recalled product is to be handled and disposed.

Contacting FDA

Once the health-hazard assessment has been conducted, the critical-information list has been assembled and the recall strategy has been organized, the FDA regional office recall coordinator is consulted to discuss the product failure and the company's proposed course of action.

The product details are submitted to FDA in the form of a recall submission document, which contains all the details that are necessary for FDA to evaluate the product failure, how that product failure will affect consumer safety, and the adequacy of the planned course of action. This includes product details, a description of the problem, distribution information, the health-hazard assessment, and the proposed recall strategy.


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