← FDA ENFORCEMENT
D-0160-2025Class II

Glenmark Pharmaceuticals Inc., USA

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Ongoing
Report date
2025-01-01
Distribution
USA Nationwide
Firm state
NJ
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

Lot#: 17230133, Exp 12/31/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.