Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera...

FDA Recall #D-0149-2024 — Class III — November 20, 2023

Recall #D-0149-2024 Date: November 20, 2023 Classification: Class III Status: Completed

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

Reason for Recall

Failed Dissolution Specifications

Recalling Firm

Siegfried Barbera, SL — Barbera Del Valles, N/A

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2016

Distribution

Nationwide

Code Information

Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated