Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl (diltiazem hydrochloride) Extended-release Capsules, USP 120 mg because the medication failed testing for impurities. Tests showed that a related chemical compound within the drug exceeded the approved degradation specifications set by the manufacturer. The recall affects 80-count cartons (packaged as 8 blister cards of 10 capsules each) that were distributed nationwide. Consumers should consult their doctor or pharmacist regarding the continued use of this medication and to obtain a replacement.
The presence of impurities or degradation products above the approved limit can mean the medication is not meeting quality standards, which could potentially affect the drug's performance or safety profile during treatment.
Pharmacist or healthcare provider consultation and product refund.
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Sources: FDA iRES · Raw API Response
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