Lupin Pharmaceuticals Inc. is recalling 44,640 bottles of Lovastatin (lovastatin) Tablets USP, 40 mg, because the drug substance used to manufacture them was found to contain impurities that exceeded approved safety specifications. This recall affects 60-count and 100-count bottles that were distributed across the United States and Puerto Rico. Consumers currently taking this medication should not stop treatment but should contact their healthcare provider or pharmacist immediately to discuss the recall and obtain a safe replacement.
The drug substance used in these tablets fell out of specification for individual impurity results during manufacturing. While the recall is classified as low risk, impurities exceeding set limits can potentially affect the quality and long-term safety profile of the medication.
Contact healthcare provider and return product for refund.
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Sources: FDA iRES · Raw API Response
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