FDAHealthOctober 18, 2024

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

⚠️ Labeling: Label Mix-Up

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: October 18, 2024

Nationwide within the United States

What's affected?

Product: Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Brand: SUNITINIB MALATE
Lot code: 100049501

Additional details

Lot #: 100049501, Exp. Date 07/31/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 20 bottles.

View original FDA notice →

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