Recalls / Class III
Class IIID-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
- Brand name
- Votrient
- Generic name
- Pazopanib Hydrochloride
- Active ingredient
- Pazopanib Hydrochloride
- Route
- Oral
- NDC
- 0078-1077
- FDA application
- NDA022465
- Affected lot / code info
- Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Siegfried Barbera, SL
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- Ronda De St Maria 158, N/A, Barbera Del Valles, N/A N/A, Spain
Distribution
- Quantity
- 2016
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-11-20
- FDA classified
- 2023-12-13
- Posted by FDA
- 2023-12-20
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0149-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.