Drug 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
D-0149-2024
Product summary
- Event
- Event 93429
- Status
- Completed
- Classification
- Class III
- Quantity
- 2016
- Official record key
drug-enforcement:D-0149-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications