D-0451-2025 Class II Ongoing
FDA drug recall D-0451-2025 was initiated by Glenmark Pharmaceuticals Inc., USA on February 28, 2025 and is designated Class II. Reason for recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit The recall status is ongoing. Affected quantity: 18,696 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 4, 2025
- Initiation Date
- February 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,696 bottles
Product Description
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
Distribution Pattern
U.S. Nationwide
Code Information
Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26