Glenmark Pharmaceuticals Inc., USA is voluntarily recalling 6,759 bottles of Ezetimibe and Simvastatin Tablets (10mg/40mg), a prescription medication used to lower cholesterol. The recall was initiated because a long-term stability study found that levels of an impurity known as Anhydro Simvastatin exceeded approved limits at the six-month mark. Consumers who are currently taking this medication should contact their healthcare provider or pharmacist for guidance.
The presence of impurities above approved levels indicates the medication may not meet quality and purity standards throughout its intended shelf life. While no injuries have been reported, degradation of drug substances can potentially affect the medication's safety or effectiveness.
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Recall #: D-0462-2025. Manufactured by: Glenmark Pharmaceuticals Ltd., Madya Pradesh, India.
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Sources: FDA iRES · Raw API Response
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