FDAHealthFebruary 28, 2025
Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahw
⚠️ CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 28, 2025
U.S. Nationwide
What's affected?
- Product
- Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
- Brand
- CARVEDILOL
- UPC
- 0368462162019
- Lot code
- 19231107
Additional details
Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 18,696 bottles.
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