Drug product
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
D-0636-2025
Product summary
- Event
- Event 97534
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0636-2025
Official wording
Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Code information: Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations