Status
Ongoing
Drug Enforcement D-0215-2025
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Classification
Class II
Report Date
February 12, 2025
Termination Date
—
Product Information
- Product description
- Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
- Product quantity
- —
- Reason for recall
- CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S
Location & Firm
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address
-
750 Corporate Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0215-2025
- Event ID
- 96162
- Recall initiation date
- January 22, 2025
- Center classification date
- February 3, 2025
- Code info
- Lot numbers: a) 17230500, 17230509,17230526,17230546,17230551,17230603,17230628, 17230642,17230645,17230681, Exp.:02/2025; 17230829,17230832,17230854, 17230864,17230874,17230876,17230889,17230894, Exp.: 03/2025; 17230960, 17230964,17230976,17230981,17230985,17231161,17231171, Exp.: 04/2025 17231315,17231318,17231332,17231333,17231365, Exp.: 05/2025; 17231539, 17231563, Exp.: 06/2025; 17231653,17231662,17231663,17231680,17231691, 17231781,17231782,17231789, Exp.: 07/2025;17231838,17231880, Exp.: 08/2025; 17232144,17232147,17232151, Exp.: 09/2025; 17232369,17232370,17232408,17232409, 17232416,17232504,17232522,17232531,17232538,17232543, Exp.: 11/2025; 17240377,17240385,17240415,17240422,17240430,17240510, Exp.: 02/2026. b) 17230551, 17240377, Exp.:02/2025
- More code info
- —