Drug & medication recalls Moderate risk

AvKARE recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-9…

Recall date
October 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0103-2025
FDA classification
Class II
Brand / firm
AvKARE
Sold / distributed
Nationwide within the United States

Why it was recalled

Labeling: Label Mix-Up

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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