DOFETILIDE Recall D-1082-2023
Description: Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
DOFETILIDE Recall D-1082-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1082-2023 |
| Event ID | 92725 |
| Brand | DOFETILIDE |
| Generic Name | DOFETILIDE |
| Manufacturer | DOFETILIDE |
| Original Package? | 1 |
| Active Substance | DOFETILIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 360 60-count bottles |
| Recall Reason | Out of Specification result observed in content uniformity testing |
| Drug Classification | Class III |
| Drug Code Info | 20230816 |
| Product NDC | 47335-061 47335-062 47335-063 |
| Product NUI | N0000175426 |
| Drug UPC | 0347335063868 0347335062861 0347335061864 |
| Pharma Class (EPC) | Antiarrhythmic [EPC] |
| Recall Initiation Date | 20230718 |
| Report Date | 20230816 |
| Classification Date | 20230807 |
| Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
| Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | R4Z9X1N2ND |
| Drug Application Number | ANDA210466 |
| Structured Product Labeling (SPL ID) | b3ed4088-3a45-4c61-9124-fd590ebf57e1 |
| Structured Product Labeling (SPL Set ID) | e6caaf44-4a3e-46ef-85fa-f97f682fbdd6 |
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