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FDARecalled Oct 15, 2025 · #D-0011-2026

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Classification: Class II Distribution: Nationwide

Product details

Product
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
Type
Drugs
Manufacturer
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Model numbers
UPCs