Status
Ongoing
Drug Enforcement D-0449-2025
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 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Product quantity
- [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 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-0449-2025
- Event ID
- 96861
- Recall initiation date
- February 28, 2025
- Center classification date
- May 28, 2025
- Code info
- [100-Count Bottles] Lot 19231618, exp Mar-25; 19232064, exp Apr-25; 19232324, May-25; 19233369, Exp Jul-25; Lot 19234162, Exp Sep-25; Lot 19240543, Exp Jan-26 [500-Count Bottles] Lots 19231174, 19231199, 19231164, Exp Feb-25, 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,19231638, 19231448, Exp Mar-25, 19232043,19232051,19232064, Apr-25, 19232322, 19232324, 19232365, 19232380, 19232389, Exp May-25; Lots 19232736, 19232743, 19232746, 19232756, 19232757, Exp Jun-25; Lots 19233369, 19233371, 19233405, 19233416, Exp Jul-25; Lots 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242, Exp Sep-25; Lots 19234743, 19234774, 19234993, Exp Nov-25; Lots 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319, Exp Dec-25; Lot 19240543, Exp Jan-26
- More code info
- —