Drug product
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
D-0309-2025
Product summary
- Event
- Event 95658
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8160 bottles
- Official record key
drug-enforcement:D-0309-2025
Official wording
Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Code information: Lot#s: 17232222 and 17232237, Exp 10/31/2025
Distribution pattern: Nationwide in the USA and PR
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso-Desmethyl Chlorpromazine impurity
-
Manufacturing or process control
CGMP deviations