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The Product Recall Process for Food and Drugs

Whenever there’s a health risk posed by food or drugs being sold to the public, the U.S. Food and Drug Administration has responsibility for monitoring and, if necessary, removing those products that pose safety risks. This blog post provides an overview of how food and drug recalls work.

Drug Recalls

A drug recall can be initiated by the FDA or by a drug manufacturer. In fact, more often than not, it’s the drug manufacturer who commences the process. The manufacturer notifies the FDA, submits progress reports on the status of the recall, and follows up with the FDA to make certain the recall achieved its objectives.

The FDA may request that a pharmaceutical company voluntarily recall a drug, based on concerns or reports about dangers associated with the product. If the manufacturer does not comply, the FDA has the authority to ask a court of law to force a recall, or to even seize the drug. Once a recall has been initiated, the drug manufacturer must notify all direct accounts, requesting that wholesalers or retailers immediately stop selling the drug.

Food Recalls

Food items may be recalled if they are contaminated or mislabeled, as well as when they do not conform to product specifications or are missing appropriate warnings.

As with drug recalls, most food recalls are initiated by either producers or resellers of food products. With food, however, the FDA and the U.S. Department of Agriculture (USDA) share regulatory responsibility. Unlike drug recalls, all food recalls are voluntary. Though the FDA and the USDA can request that food products be recalled, they do not have authority to mandate a recall, but they can detain a product or go to court to seek an injunction, preventing a producer from operating.

The FDA and USDA generally classify a recall according to the degree of risk involved. Health hazards that have a reasonable probability of death or serious injury (such as E. coli contamination or peanut/egg products not listed on a label) are the most serious and will generally elicit a Class I recall request.

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