Drug Enforcement D-0149-2024

Failed Dissolution Specifications

Status

Completed

Classification

Class III

Report Date

December 20, 2023

Termination Date

—

Product Information

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
Product quantity
2016
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Siegfried Barbera, SL
Address
Ronda De St Maria 158, N/A

Spain
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0149-2024
Event ID
93429
Recall initiation date
November 20, 2023
Center classification date
December 13, 2023
Code info
Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
More code info
—