FDA recall D-0103-2025

Product

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

Reason for recall

Labeling: Label Mix-Up

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2024-10-18

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2025