FDA-Drug2025-10-15Class II

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Sold states
Nationwide
Affected count
2064 blister packs
Manufactured in
341 Mason Rd, La Vergne, TN, United States
Products
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2026

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