New drug recall includes more than 140K bottles of popular statin
The U.S. Food and Drug Administration (FDA) has shared details about a new recall impacting more than 140,000 bottles of a popular statin. This is a Class II recall, which means taking the drug “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The medication in question is atorvastatin calcium, a generic version of Lipitor manufactured by India-based Alkem Laboratories and distributed by New Jersey-based Ascend Laboratories. The drug is commonly prescribed to help patients lower their cholesterol levels as well as reduce their risk of adverse cardiovascular events.
According to the FDA, several lots of atorvastatin calcium were recalled due to “failed dissolution specifications.” This means the drug is not dissolving correctly, which can impact its ability to lower a patient’s cholesterol as intended.
Ascend Laboratories initiated the recall back in September. It was classified a Class II recall on Oct. 10.
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Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.