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Over 140,000 bottles of Atorvastatin Calcium Tablets, a cholesterol-lowering medication, are being recalled due to "failed dissolution specifications," according to the Food and Drug Administration (FDA). The recall affects several bottle sizes of the 10-mg prescription-only tablets, which are the generic form of Lipitor. This medication is used to lower cholesterol and reduce the risk of heart disease, heart attacks, and strokes.
The FDA classifies this as a Class II recall, indicating that the use of the product may cause temporary or medically reversible adverse health consequences. The recall involves eight lot numbers with expiration dates ranging from July 2026 to February 2027. The affected bottles come in sizes of 90, 500, and 1,000 tablets. The medication was manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories LLC in New Jersey.
Failed dissolution specifications mean the drug does not dissolve properly in laboratory testing, potentially affecting its effectiveness in controlling cholesterol levels. The FDA has not yet provided specific guidance on what consumers should do with the recalled medication. Consumers are advised to check the lot number on their medication and consult their healthcare provider or pharmacist for further instructions.