Class II
Ongoing
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
This recall is currently active, issued October 15, 2025. It was issued by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories.
- Recall Initiated
- September 12, 2025
- Posted
- October 15, 2025
- Recall Number
- D-0010-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1256 blister packs
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Distribution
Nationwide
Lot / Code Info
Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
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