...enforced the agency.

Compared to court actions, which can be time-consuming and costly, a voluntary approach to recalls is preferable. "It's the most efficient and effective way to get defective products off the market quickly and protect the public health," says David Elder, director of the FDA's Office of Enforcement.

The FDA handles recalls for all the products it regulates--human drugs; devices and radiation-emitting products; biologics such as vaccines and blood products; veterinary products, which include animal drugs and animal feed; cosmetics; and about 80 percent of the foods consumed in the United States. The Food Safety and Inspection Service, part of the U.S. Department of Agriculture (USDA), handles recalls for meat, poultry, and certain egg products.

Types of Voluntary Recalls

Sometimes, a company discovers a problem with a product and then contacts the FDA. That's what happened in a highly unusual recall announced in February 2006 by Mead Johnson, based in Evansville, Ind., for a batch of its 24-ounce cans of GENTLEASE powdered infant formula.

Mead Johnson informed the FDA that metal particles were found in lot number: BMJ 19, with a use by date of July 1, 2007. About 41,464 cans of this lot of recalled product were distributed beginning in December 2005 through retail stores nationwide. No illnesses had been reported at the time of the recall, but officials were concerned that the particles could damage the baby's respiratory system and throat, causing coughing, difficulty swallowing, or difficulty breathing.

In other instances, a company recalls the product after the FDA raises concerns. This action could occur after the agency inspects a manufacturing facility or evaluates reports of health problems. For example, the Cold Stone Creamery, in Arizona, removed all of its "cake batter" ice cream products from store shelves in July 2005 after the FDA told the company that several cases of Salmonella Typhimurium infection occurred among people who had eaten the cake batter products. This type of salmonella can cause abdominal pain, high fever, nausea, and vomiting in healthy people and can cause serious and sometimes fatal infections in small children, older people, and in those with weakened immune systems.

In rare cases, the FDA "requests" a recall. An example of this type of recall occurred in February 2006, when the FDA asked Cytosol Laboratories Inc. of Braintree, Mass., to recall all brands and sizes of its Balanced Salt Solution (BSS), which health professionals use to irrigate patients' eyes, ears, nose, or throat during cataract surgery and other procedures. The FDA requested the recall because product lots were found to have elevated levels of endotoxins, substances found in certain bacteria that can cause...

NOTE: All illustrations and photos have been removed from this article.



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