FDAFDA · Food and drugs·Recall number D-0013-2026
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
Published October 15, 2025 · Recall initiated: September 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Distributor
- Nationwide
- Lot
- Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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