FDA recall D-0149-2024

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

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status

Completed

Initiation date

2023-11-20

Report date

2023-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Barbera Del Valles, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0149-2024