Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski,...
FDA Recall #D-0103-2025 — Class II — October 18, 2024
Product Description
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
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
40 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: 100049371, Exp. Date 07/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated