FDAHealthMarch 11, 2025
Glenmark Pharmaceuticals Inc., USA — chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product
⚠️ CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 11, 2025
Nationwide in the USA and PR
What's affected?
- Product
- 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
- UPC
- 0368462862018
- Lot code
- 17232222
Additional details
Lot#s: 17232222 and 17232237, Exp 10/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8160 bottles.
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