Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0309-2025

D-0309-2025 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
April 9, 2025
Initiation Date
March 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8160 bottles

Product Description

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.

Distribution Pattern

Nationwide in the USA and PR

Code Information

Lot#s: 17232222 and 17232237, Exp 10/31/2025

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