SUNITINIB MALATE Recall D-0103-2025
Description: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
SUNITINIB MALATE Recall D-0103-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0103-2025 |
| Event ID | 95596 |
| Brand | SUNITINIB MALATE |
| Generic Name | SUNITINIB MALATE |
| Manufacturer | SUNITINIB MALATE |
| Active Substance | SUNITINIB MALATE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 40 bottles |
| Recall Reason | Labeling: Label Mix-Up |
| Drug Classification | Class II |
| Drug Code Info | 20241211 |
| Product NDC | 42291-901 42291-902 42291-903 |
| Recall Initiation Date | 20241018 |
| Report Date | 20241211 |
| Classification Date | 20241204 |
| Address | 615 N 1st St Pulaski, TN 38478-2403 United States |
| Recalling Firm | AvKARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | LVX8N1UT73 |
| Drug Application Number | ANDA213803 |
| Structured Product Labeling (SPL ID) | 0772f635-a03d-3c10-e063-6294a90a67ad |
| Structured Product Labeling (SPL Set ID) | 0772eb61-ca42-39de-e063-6294a90a6632 |
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