Drug recall D-0361-2025
Product
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
Reason for recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Lots and codes
Lot #: Z400069, Exp.: 12/31/2025
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 3144 bottles, pack size: 100's Count
- Distribution
- Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 3, 2025
Related products
- Chlorpromazine Hydrochloride – drug information
- NDC 70710-1133 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 200 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1132 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 100 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1130 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 25 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1129 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 10 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1131 Chlorpromazine hydrochloride · Chlorpromazine Hydrochloride 50 mg/1 · Zydus Pharmaceuticals (USA) Inc.