FDAHealthSeptember 12, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distri
⚠️ 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, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
- Lot code
- N01920
Additional details
Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 866 blister packs.
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