CARVEDILOL Recall D-0216-2025
Description: Carvediol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CARVEDILOL Recall D-0216-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0216-2025 |
| Event ID | 96162 |
| Brand | CARVEDILOL |
| Generic Name | CARVEDILOL |
| Manufacturer | CARVEDILOL |
| Original Package? | 1 |
| Active Substance | CARVEDILOL |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S |
| Recall Reason | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. |
| Drug Classification | Class II |
| Drug Code Info | 20250212 |
| Product NDC | 68462-162 68462-163 68462-164 |
| Product NUI | N0000000099 N0000009923 N0000009924 |
| Pharma Class (EPC) | alpha-Adrenergic Blocker [EPC] |
| Recall Initiation Date | 20250122 |
| Report Date | 20250212 |
| Classification Date | 20250203 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 0K47UL67F2 |
| Drug Application Number | ANDA078251 |
| Structured Product Labeling (SPL ID) | 2155a4b3-b3d1-4dba-81d9-b8b7f7fe2cce |
| Structured Product Labeling (SPL Set ID) | c4a21f67-7812-4634-beba-f8e85c63c5f2 |
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