Class II
Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
- Recall Initiated
- December 11, 2024
- Posted
- January 1, 2025
- Recall Number
- D-0159-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,888
- Firm Location
- Mahwah, NJ, United States
Reason for Recall
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Distribution
USA Nationwide
Lot / Code Info
Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
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