Drug recall D-0451-2025
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.
Reason for recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots and codes
Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 18,696 bottles
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 28, 2025
Related products
- Carvedilol – drug information
- NDC 68462-164 Carvedilol · Carvedilol 12.5 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-163 Carvedilol · Carvedilol 6.25 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-165 Carvedilol · Carvedilol 25 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-162 Carvedilol · Carvedilol 3.125 mg/1 · Glenmark Pharmaceuticals Inc., USA