FDA Recall D-0309-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 429 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 8160 bottles

Reason for recall

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

Recall record

Recall number: D-0309-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and PR
Recall initiated: 2025-03-11
Classified by FDA Center: 2025-04-02
FDA published: 2025-04-09
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): CHLORPROMAZINE HYDROCHLORIDE
Generic name(s): CHLORPROMAZINE HYDROCHLORIDE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-861, 68462-862, 68462-863, 68462-864, 68462-865
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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