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What is the FDA’s involvement in recalls?

Every year, thousands of medical devices and medications are recalled. Like others, some Ohio residents may wonder how the Food and Drug Administration is involved in this process. As of right now, the FDA cannot force a company to recall a product; it is up to the manufacturers to do the right thing.

With the recent increase in recalls of over-the-counter medications, the perception may be growing that the FDA needs the power to force companies to remove their products from the market. For now, the agency’s role focuses on making sure the recall is appropriate, giving it a classification, and supervising the response and strategy of the company involved. Getting the word out to everyone, such as medical providers, pharmacists and even consumers, will then begin in earnest. The classification may be one of the most important pieces of information consumers need.

The FDA uses three classifications for recalls. The least dangerous is a Class III, which means the risk to people is low. A Class II recall means the risk to individuals is a real threat, and a Class I recall indicates the potential for serious harm or death.

The problem with recalls is they do not happen until hundreds of thousands, perhaps millions, of people have already been prescribed or used the medication or medical device involved. The harm may already have occurred to unsuspecting individuals. Ohio residents could currently be taking a medication or using a medical device that could end up on an FDA list of recalls tomorrow, next week or at some other point in the future.

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