Mylan Pharmaceuticals Inc. is recalling 12,455 bottles of Diltiazem HCl Extended-Release Capsules (USP 120 mg) because routine testing showed the drug contained impurities that exceeded approved limits. The recall includes approximately 11,799 bottles of the 100-count size and 656 bottles of the 500-count size, all from a single batch with an expiration date of April 2019. Diltiazem is a prescription medication used to treat high blood pressure and chest pain. Consumers should contact their healthcare provider or pharmacist for guidance on using this medication, as degradation of the product may impact its effectiveness.
Routine stability testing found that levels of a related chemical compound in the capsules were higher than the required safety and quality specifications. This indicates the medication is degrading faster than intended, which could potentially alter the drug's performance or safety profile.
Consult pharmacist and return product.
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Sources: FDA iRES · Raw API Response
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