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.