Drug product
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
D-0159-2025
Product summary
- Event
- Event 95936
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,888
- Official record key
drug-enforcement:D-0159-2025
Official wording
Reason: CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Code information: Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso-Desmethyl Chlorpromazine impurity
-
Manufacturing or process control
CGMP Deviations