Status
Ongoing
Drug Enforcement D-0448-2025
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Classification
Class II
Report Date
June 4, 2025
Termination Date
—
Product Information
- Product description
- Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Product quantity
- [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
- Reason for recall
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
Location & Firm
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address
-
750 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0448-2025
- Event ID
- 96861
- Recall initiation date
- February 28, 2025
- Center classification date
- May 28, 2025
- Code info
- [100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lots 19234843, 19235039, Exp Nov-25; Lots 19240280, 19240296, Dec-25
- More code info
- —