Sunitinib Malate Capsule
FDA Recall NDC 0093-8199
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sunitinib Malate (NDC 0093-8199). A significant event, classified as Class II, was initiated on Jul 05, 2023 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Moisture Limits: Water (moisture) content above the approved product specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Jul 05, 2023
Jul 19, 2023
180 bottles
Recall Profile & Regulatory Data
Event ID
92636
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Termination Date
Jan 10, 2024
Product Description
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Batch or Lot Expiration Information
Lot# 100037220, Exp 10/2024
Affected Packages Involved in this Recall
0093-8199-28Product
0093-8224-28Product
0093-8229-28Product
0093-8231-28Product
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.
