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What is the role of the FDA in a product recall?

When a product that is regulated by the U.S. Food & Drug Administration is discovered to be defective or to present a health risk, the first notice the public receives of the problem is often the announcement of a product recall. The FDA has broad authority under federal law to regulate the safety of prescription drugs, medical devices, cosmetics and most of the food products consumed in the U.S.

The FDA learns of a potential problem with a product in a number of ways. With food products, the FDA is usually contacted by the Centers for Disease Control and Prevention, an agency which learns of outbreaks of food-borne illness from state health authorities. Sometimes a company discovers a product defect and notifies the FDA itself. The FDA also learns of product safety issues through its inspection program and through a number of reporting systems it has in place.

Most recalls are voluntary, and are often undertaken after the company itself discovers a problem. The FDA will sometimes raise concerns about a product and the company will respond with a voluntary recall. Only occasionally does the FDA actually request a recall. When a recall is announced, the FDA's role is to monitor the company's efforts and evaluate the sufficiency of the recall.

A food or prescription drug recall often alerts consumers that an illness or injury they have suffered may have been caused by a defective product. When this occurs, the consumer might consider a product liability lawsuit in order to pursue compensation.

Source: U.S. Food & Drug Admin., "FDA 101: Product Recalls," accessed Oct. 5, 2015

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