CHLORPROMAZINE HYDROCHLORIDE
Wed Apr 09 2025
1 of 7
Summary
CGMP deviations: Results of the finished product is above the Agency's current recommended limit of a nitrosamine, N-Nitroso-Desmethyl Chlorpromazine impurity.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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 68462-862-01 | Glenmark Pharmaceuticals Inc., USA | Nationwide in the USA and PR | 8160 bottles |