Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
- Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
- Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.
- Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
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.
What to Do if a Drug You’re Taking Is Recalled
If the recall involves an over-the-counter drug, stop taking it at once. You can return the product to the place of purchase and ask for a refund — stores generally have return and refund policies when a recall has been issued. Your doctor or pharmacist can recommend an alternative medicine to use during the recall. Manufacturers will also have a hotline number to contact for more information.
If the recall involves a prescription drug, call your doctor or pharmacist as soon as possible to find out what replacement is needed.
Jonnalagadda Lakshmana Rao
B.Pharma, Andhra University