FDA Product Recalls

by Food and Drug Administration (FDA)

Most recalls of products regulated by the Food and Drug Administration are voluntary. One way or another, a company discovers a problem or a potential problem and then initiates a product recall in cooperation with the FDA. A recall is a way to remove or correct products that violate laws enforced by 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: BMJ19, 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 fever, shock, and changes in blood pressure and in other circulatory functions.

The FDA has received reports of a serious eye injury called Toxic Anterior Segment Syndrome (TASS), as well as complaints relating to injuries in more than 300 people who were given BSS. An estimated 1 million units of BSS products manufactured by Cytosol were distributed between December 2003 and December 2005.

In response to the FDA's request, Cytosol voluntarily recalled the following products: AMO Endosol, distributed by Advanced Medical Optics Inc., Santa Ana, Calif.; Cytosol Ophthalmics, distributed by Cytosol Ophthalmics, Lenoir, N.C.; and Akorn, distributed by Akorn Inc., Buffalo Grove, Ill.

Whatever the reason for a voluntary recall, the FDA's role is to oversee the company's recall strategy. In 2003, the agency released guidance for industry on managing all aspects of a recall. "The guidance assists the firm in recall strategy development, and encourages firms to provide the information FDA needs to evaluate and classify the recall," Elder says.

Evaluating the Health Hazard

For any product regulated by the FDA, a recall is handled by the appropriate FDA product center. A recall of a blood product, for example, would be addressed by the FDA's Center for Biologics Evaluation and Research. A recall of a drug for dogs would fall with the FDA's Center for Veterinary Medicine.

Once a recalled product is referred, the center convenes a board of experts who evaluate the health hazard associated with the recall. Scientists evaluate factors such as whether any diseases and injuries have already occurred; what risks apply to various segments of the population, including children, pets, and surgical patients; the degree of seriousness of the health hazard; and the volume of product involved and the distribution.

"Based on all of this information, the experts assign the recall a classification to indicate the relative degree of the health hazard, with Class I being the most serious," says Pete Cook, an FDA recall coordinator.

Here's a look at the classes of recalls:

Class I: A Class I recall involves a situation in which there is reasonable probability that the use of or exposure to the product will cause serious health problems or death. After a physician reported confusion over a dosing syringe, the Perrigo Co. of Allegan, Mich., initiated a voluntary recall in August 2005 of lots of liquid concentrated infants' oral drops that were packaged with a dosing syringe bearing only a 1.6-milliliter mark. The products included pain relievers containing acetaminophen and cough and cold drops. The drops were recalled because the dosing syringe could be confusing in determining the proper dose for infants younger than 2 years and could lead to overdosing, which could be fatal.

Class II: A Class II recall means that the use of or exposure to the product may cause temporary or medically reversible health problems or that the probability of serious health problems is remote. McNeil Consumer & Specialty Pharmaceuticals of Fort Washington, Pa., was involved in a Class II action when it recalled 4-ounce bottles of Children's Motrin Dye-Free Berry Flavor Liquid in September 2005. Some of the products intended for destruction because of "black specks" and "foreign organic material" were possibly sent to retail stores.

Class III: A Class III recall is the least serious and indicates that exposure to the product is not likely to cause health problems. The American Bottling Co. of Ottumwa, Iowa, had a Class III recall in August 2005, when it recalled certain cases of A & W Sparkling Vanilla Cream Soda that were labeled as caffeine-free. The bottles of soda actually contained caffeine.

In 2005, more than 5,300 products regulated by the FDA were recalled. Of these products, 466 were Class I, 3,781 were Class II, and 1,091 were Class III. Most Class I recalls in 2005 were in the food category.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.