Recall D-0309-2025

US Class II Ongoing · initiated 2025-03-11

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

Reason for recall

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

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