PlainRecalls
FDA Drug Moderate Class II Ongoing

Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28

Reported: December 11, 2024 Initiated: October 18, 2024 #D-0104-2025

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

Details

Recalling Firm
AvKARE
Units Affected
20 bottles
Distribution
Nationwide within the United States
Location
Pulaski, TN

Frequently Asked Questions

What product was recalled?
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28. Recalled by AvKARE. Units affected: 20 bottles.
Why was this product recalled?
Labeling: Label Mix-Up
Which agency issued this recall?
This recall was issued by the FDA Drug on December 11, 2024. Severity: Moderate. Recall number: D-0104-2025.