November 2023 FDA Recall Votrient by Siegfried Barbera, Sl
D-0149-2024 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Siegfried Barbera, Sl on November 20, 2023 for the product Votrient. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0149-2024
Failed Dissolution Specifications
11-20-2023
12-20-2023
2016
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Siegfried Barbera, SL
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
