Class II · Moderate risk Ongoing
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Reason Labeling: Label Mix-Up
Is Sunitinib recalled?
3 FDA recalls mention Sunitinib. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sunitinib.
Class II · Moderate risk Ongoing
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Reason Labeling: Label Mix-Up
Class II · Moderate risk Terminated
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ…
Reason Failed Moisture Limits: Water (moisture) content above the approved product specifications.
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