Sunitinib Malate Capsule
FDA Recall NDC 42291-901
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sunitinib Malate (NDC 42291-901). A significant event, classified as Class II, was initiated on Oct 18, 2024 by Avkare. The reported reason for this action was: "Labeling: Label Mix-Up"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Labeling: Label Mix-Up
Oct 18, 2024
Dec 11, 2024
20 bottles
Recall Profile & Regulatory Data
Event ID
95596
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
Batch or Lot Expiration Information
Lot# : 100049501, Exp. Date 07/31/2026
Affected Packages Involved in this Recall
42291-901-28Product
42291-902-28Product
42291-903-28Product
42291-904-28Product
Class II Ongoing
Labeling: Label Mix-Up
Oct 18, 2024
Dec 11, 2024
40 bottles
Recall Profile & Regulatory Data
Event ID
95596
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
Batch or Lot Expiration Information
Lot# : 100049371, Exp. Date 07/31/2026
Affected Packages Involved in this Recall
42291-901-28Product
42291-902-28Product
42291-903-28Product
42291-904-28Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
