Drug product

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

D-0160-2025

December 11, 2024

Class II

Product summary

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

Code information: Lot#: 17230133, Exp 12/31/2024

Distribution pattern: USA Nationwide

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-Nitroso-Desmethyl Chlorpromazine impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations