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What Is a Drug Recall?

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Medicine is rigorously tested for safety and effectiveness before becoming available to the consumer. In the U.S., the FDA makes sure this happens. Once on the market, the FDA, along with the makers of the drug, continue to monitor the medicine for any unforeseen problems. Should an issue develop, or the safety of a medication come into question, a recall may be initiated.

When Is a Drug Recall Announced?

A drug recall occurs when a prescription or over-the-counter medicine is removed from the market because it is found to be either defective or potentially harmful. Sometimes, the makers of the drug will discover a problem with their drug and voluntarily recall it. Other times, the FDA will request that the medicine be recalled after receiving reports of problems from the public.  

Why Are Drugs Recalled?

A number of factors can cause a drug to be recalled. A recall may be issued if a medicine:

Is a health hazard. Unfortunately, some health risks associated with certain medications are not realized until after they become widely used. For example, in 2000, medicines containing the drug phenylpropanolamine (PPA), such as certain decongestants and weight loss medicines, were recalled after learning that PPA increases the risk of hemorrhagic stroke, or bleeding in the brain. Another example is the weight loss drug Meridia (sibutramine). Meridia was recalled from the U.S. market in 2010 after it was found to increase a person's risk of heart attack and stroke.

Is mislabeled or packaged poorly. Sometimes a medicine is recalled because of confusing dosing instructions or a problem with the dosing tool provided with the drug.

Is potentially contaminated. During production or distribution, a medicine may become contaminated with a harmful or non-harmful substance.

Is not what it says. For example, you may think you are taking a pain reliever based on the package material, when in fact what is inside the box is something else.

Is poorly manufactured. Manufacturing defects related to a product’s quality, purity, and potency may be to blame for a drug recall. 

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