Sunitinib Malate Capsules recall: Labeling Error
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Why was Sunitinib Malate Capsules recalled?
Labeling: Label Mix-Up
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 100049501, Exp. Date 07/31/2026
- Product
- Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
- Recalling firm
- AvKARE
- Quantity
- 20 bottles
- Distribution
- Nationwide within the United States
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)