Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Val
Summary
The FDA issued a Class III for Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: by Siegfried Barbera, SL. Reason: Failed Dissolution Specifications.
Details
Source
Drug Recall
External ID
D-0149-2024
Action Date
2023-12-20
Status
Completed
Category
drug
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
Lot/Code Info: Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
Quantity Affected: 2016
Reason for Recall
Failed Dissolution Specifications
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-20
Company
Barbera Del Valles, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 30 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siegfried Barbera, SL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siegfried Barbera, SL have FDA actions?
This is the only FDA action we have on record for Siegfried Barbera, SL in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0149-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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