ownitsafely
Back to recalls

FDARecalled Apr 23, 2025 · #D-0366-2025

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

Hazard

Class II — temporary health risk

Be the first to hear about future recalls.

Add the things you own to a watchlist. We’ll alert you the moment one matches.

Get started, free

Description

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit Classification: Class II Distribution: Nationwide USA

Product details

Product
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
Type
Drugs
Manufacturer
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Model numbers
N02114
UPCs