Class II
Ongoing
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
This recall is currently active, issued April 23, 2025. It was issued by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories.
- Recall Initiated
- April 14, 2025
- Posted
- April 23, 2025
- Recall Number
- D-0366-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 133 cartons
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Distribution
Nationwide USA
Lot / Code Info
Lot#: N02114, Exp 12/31/2025
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