Recalls / Class II
Class IID-0103-2025
Product
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
- Brand name
- Sunitinib Malate
- Generic name
- Sunitinib Malate
- Active ingredient
- Sunitinib Malate
- Route
- Oral
- NDCs
- 42291-901, 42291-902, 42291-903, 42291-904
- FDA application
- ANDA213803
- Affected lot / code info
- Lot #: 100049371, Exp. Date 07/31/2026
Why it was recalled
Labeling: Label Mix-Up
Recalling firm
- Firm
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 40 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-10-18
- FDA classified
- 2024-12-04
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0103-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.