D-0104-2025 Class II Ongoing
FDA drug recall D-0104-2025 was initiated by AvKARE on October 18, 2024 and is designated Class II. Reason for recall: Labeling: Label Mix-Up The recall status is ongoing. Affected quantity: 20 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- October 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 bottles
Product Description
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Reason for Recall
Labeling: Label Mix-Up
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 100049501, Exp. Date 07/31/2026