FDAHealthDecember 11, 2024
Glenmark Pharmaceuticals Inc., USA — chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-0
⚠️ 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, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
- UPC
- 0368462862018
- Lot code
- 17230133
Additional details
Lot#: 17230133, Exp 12/31/2024
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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