FDA and the Recall Process

The U.S. Food and Drug Administration (FDA) is responsible for monitoring adverse product experiences. If a product is deemed defective by the FDA, the FDA is authorized to request that members of industries regulated by the FDA recall the product. The FDA is also authorized to mandate product recalls under certain circumstances. Specifically, mandatory recalls can be issued for infant formula, medical devices and human biological products. When a product is recalled, the manufacturer or importer provides information about the product to the FDA. The FDA then uses the information provided to evaluate, classify, monitor and audit the product recalls.

The FDA requests that firms responsible for a recalled product provide the following product information to the FDA: the product name; its model or catalog number; its intended use or uses; its shelf life, if any; and samples of labels and packaging, including package inserts and promotional materials. Additional information is required for drug, medical device, and biological recalls. In addition, the firm must include the reason for the recall, including how the product is defective or violative of FDA requirements, how the defect affects the safety of the product, how the problem occurred, how the problem was discovered, and how the problem was isolated in certain batches of the product if such is claimed. Detailed information as to the complaints associated with the problem must also be provided, including the number of complaints, the dates of each, and the details of any resulting illness or injury.

In addition to providing information, the FDA usually requires that a press release be issued warning the public of the product's problem. The press release should be approved by the FDA District Recall Coordinator and may be issued jointly with the FDA. If the firm fails or refuses to issue a press release, the FDA will usually issue one. The recall instructions should be clear and should include product identification information; a description of the problem and the health hazards associated with it; and the recall instructions to customers, including where to return the product and the procedure for product correction.

After the recall, the recalling firm is responsible for making sure the recall was effective. Part of this process requires the recalling firm to provide recall status reports to the FDA, including the dates customers were notified, the number of customers notified, the number of customers responding, the quantity of the recalled product returned, and the details of the recall effectiveness checks. Prior to terminating the recall, recalling firms should communicate the root cause of the recall problem to the District Recall Coordinator and explain any corrective actions either planned or underway.

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