Class II
Ongoing
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
This recall is currently active, issued April 9, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- March 11, 2025
- Posted
- April 9, 2025
- Recall Number
- D-0309-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8160 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Distribution
Nationwide in the USA and PR
Lot / Code Info
Lot#s: 17232222 and 17232237, Exp 10/31/2025
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