Glenmark’s US arm recalling affected lot of Diltiazem Hydrochloride extended-release capsules

16 Dec 2024 Evaluate

Glenmark Pharmaceuticals’ US-based subsidiary -- Glenmark Pharmaceuticals Inc is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules in the US market due to cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Diltiazem Hydrochloride extended-release capsules are used to treat high blood pressure. The company initiated the Class II nationwide (US) recall on November 1, 2024.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. 


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