Drug 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
D-0361-2025
Product summary
- Event
- Event 96626
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3144 bottles, pack size: 100's Count
- Official record key
drug-enforcement:D-0361-2025
Official wording
Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Code information: Lot #: Z400069, Exp.: 12/31/2025
Distribution pattern: Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso-Desmethyl Chlorpromazine impurity
-
Manufacturing or process control
CGMP deviations