FDAHealthDecember 11, 2024
Glenmark Pharmaceuticals Inc., USA — chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
⚠️ CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 11, 2024
USA Nationwide
What's affected?
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
- UPC
- 0368462862018
- Lot code
- 17230132
Additional details
Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,888.
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