← FDA ENFORCEMENT
D-0149-2024Class III

Siegfried Barbera, SL

Recalling firm
Siegfried Barbera, SL
Product type
Drug
Status
Completed
Report date
2023-12-20
Distribution
Nationwide
Firm state
N/A
Product quantity
2016
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.