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Class III: unlikely to cause harmCompleted

Siegfried Barbera, SL Votrient Recall

Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegri…

Siegfried Barbera, SL · Barbera Del Valles, N/A

Risk level
Class III
Reported by FDA
Dec 20, 2023
Recall ID
D-0149-2024
Check your lot numberHow we source this data

Summary

Siegfried Barbera, SL recalled Votrient starting Nov 20, 2023. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0149-2024 on Dec 20, 2023. Reason: Failed Dissolution Specifications. Status: Completed.

Why it was recalled

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0149-2024
Classification
Class III
Status
Completed
Recall initiated
Nov 20, 2023
FDA report date
Dec 20, 2023
Quantity
2016
Recall type
Voluntary: Firm initiated
Recalling firm
Siegfried Barbera, SL

Original FDA data

Every field from FDA enforcement report D-0149-2024, exactly as published.

Show all FDA fields
City
Barbera Del Valles
Status
Completed
Country
Spain
Event ID
93429
Address
Ronda De St Maria 158
Code information
Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
Report date
Dec 20, 2023
Product type
Drugs
Recall number
D-0149-2024
Classification
Class III
Recalling firm
Siegfried Barbera, SL
Product quantity
2016
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Nov 20, 2023
Center classification date
Dec 13, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0149-2024, published Dec 20, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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