FDAApril 14, 2025drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

harvard drug group llc dba major pharmaceuticals and rugby laboratoriesharvardharvard drug

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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