Glenmark Pharmaceuticals Inc., USA is recalling 90,528 bottles of Diltiazem Hydrochloride (Diltiazem HCl) Extended-Release Capsules sold under the Glenmark and Northstar Rx brands. These prescription medications, used to treat high blood pressure and chest pain, were found to contain an impurity called N-nitroso-Desmethyl-Diltiazem at levels exceeding the FDA's recommended interim safety limit. The recall affects 60 mg, 90 mg, and 120 mg strengths distributed in 100-count bottles nationwide.
The impurity N-nitroso-Desmethyl-Diltiazem is a nitrosamine, a class of compounds that may increase the risk of cancer if individuals are exposed to them above safety levels over a long period of time. No reports of immediate illness or adverse events have been reported to date.
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Sources: FDA iRES · Raw API Response
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