FDAHealthSeptember 12, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distrib
⚠️ CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 12, 2025
Nationwide
What's affected?
- Product
- Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
- Lot code
- N01954
Additional details
Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1256 blister packs.
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