Recall D-0159-2025

US Class II Ongoing · initiated 2024-12-11

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

Reason for recall

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

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