DOFETILIDE Recall D-0384-2023
Description: Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9
DOFETILIDE Recall D-0384-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0384-2023 |
| Event ID | 91657 |
| Brand | DOFETILIDE |
| Generic Name | DOFETILIDE |
| Manufacturer | DOFETILIDE |
| Original Package? | 1 |
| Active Substance | DOFETILIDE |
| Drug Route | ORAL |
| Distribution | United States including Puerto Rico and Canada |
| Quantity | 113,571 bottles |
| Recall Reason | CGMP Deviations: recalling drug products following an FDA inspection. |
| Drug Classification | Class II |
| Drug Code Info | 20230308 |
| Product NDC | 16729-490 16729-491 16729-492 |
| Product NUI | N0000175426 |
| Drug UPC | 316729491129 |
| Pharma Class (EPC) | Antiarrhythmic [EPC] |
| Recall Initiation Date | 20230207 |
| Report Date | 20230308 |
| Classification Date | 20230302 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | R4Z9X1N2ND |
| Drug Application Number | ANDA213338 |
| Structured Product Labeling (SPL ID) | d923a6e5-7b50-ee28-e053-2a95a90ad9a3 |
| Structured Product Labeling (SPL Set ID) | 4c1a5a6d-bd69-473c-8caa-d0d242b7708d |
| Similar To |