Votrient Tablet, Film Coated
FDA Recall NDC 0078-1077
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 Votrient (NDC 0078-1077). A significant event, classified as Class III, was initiated on Nov 20, 2023 by Novartis Pharmaceuticals Corporation. The reported reason for this action was: "Failed Dissolution Specifications"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Failed Dissolution Specifications
Nov 20, 2023
Dec 20, 2023
2016
Recall Profile & Regulatory Data
Event ID
93429
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Siegfried Barbera, SL
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66
Batch or Lot Expiration Information
Lot# ME2713; Exp. 02/2025
Lot# MF8286, ML1860; Exp. 04/2025
Affected Packages Involved in this Recall
0078-1077-66Product
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.
