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How does the Food and Drug Administration issue a recall?

How does the Food and Drug Administration issue a recall?

Product recalls are a major issue that affects millions of people. They affect issues of personal safety and health and are often the foundations of legal cases. For those reasons, it is important to know basic facts about the Food and Drug Administration’s product recalls.

Why are recalls done?

Recalls are done to protect the public. The FDA determines that a product is defective or for some other reason potentially harmful. If people continued to use that product, they would be endangering their health and safety. So, the FDA issues a recall to let people know why the product is dangerous and to get it out of homes and stores.

How does the FDA become aware of product problems?

One way is the company that produces the product discovers that something is wrong and voluntarily reports the problem to the FDA. Another way is for the FDA to inspect a manufacturing facility and from doing so, comes into possession of information that prompts a recall. The FDA may also receives reports about health problems though a variety of other reporting systems or hear about them directly through the Centers for Disease Control and Prevention.

What categories of recall classifications are there?

There are three. Class I covers products that can cause serious health problems or even death. These can include foods with undeclared allergens, food containing botulinum toxin and a label mix-up on a drug meant to save lives.

Class II recalls are for products that can cause temporary problems or only a modest likelihood of serious problems. Class III recalls are for products that aren’t likely to cause adverse health reactions, but that do violate FDA manufacturing or labeling laws. By understanding these facts, you can be better prepared to deal with any recall that affects you.

Source: Food and Drug Administration, “FDA 101: Product Recalls,” accessed Nov. 17, 2015

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