D-0160-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2025
- Initiation Date
- December 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
Reason for Recall
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Distribution Pattern
USA Nationwide
Code Information
Lot#: 17230133, Exp 12/31/2024