Drug product
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
D-0103-2025
Product summary
- Firm
- AvKARE
- Event
- Event 95596
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 bottles
- Official record key
drug-enforcement:D-0103-2025
Official wording
Reason: Labeling: Label Mix-Up
Code information: Lot #: 100049371, Exp. Date 07/31/2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up