Class II
Ongoing
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
This recall is currently active, issued April 16, 2025. It was issued by Zydus Pharmaceuticals (Usa) Inc.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- April 3, 2025
- Posted
- April 16, 2025
- Recall Number
- D-0361-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3144 bottles, pack size: 100's Count
- Firm Location
- Pennington, NJ, 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 within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Lot / Code Info
Lot #: Z400069, Exp.: 12/31/2025
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