Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

For Immediate Release

July 13, 2018

Contact

Consumers

Major Pharmaceuticals Customer Support
1-800-616-2471

Media

Ellen Barry
ellen.barry@cardinalhealth.com
(614) 553-3858

Announcement

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

Major Pharmaceuticals is committed to patient safety and is partnering with the Food and Drug Administration (FDA) to notify customers who may be in possession of Valsartan tablets supplied by Teva Pharmaceuticals.  Please see the below list of affected products and lot numbers.

The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. Through recent communication with FDA, Major Pharmaceuticals learned of a potential issue with the active pharmaceutical ingredient in Valsartan supplied by Teva Pharmaceuticals which may contain the probable carcinogen N- nitrosodimethylamine (NDMA). Major Pharmaceuticals as a distribution firm, is recalling all lots within expiry of Valsartan supplied by Teva Pharmaceuticals. Major Pharmaceuticals has not received any reports of adverse events related to this recall to date.

Valsartan is a prescription medication that is commonly used to treat high blood pressure and heart failure. The product was distributed as unit dose blisters with 100 tablets per carton. The distribution firm is notifying distributors and other customers by recall letter and arranging for return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this product.  Pharmacies, and healthcare facilities that have product being recalled should stop using and dispensing the product immediately.

Consumers with questions regarding this recall should contact Major Pharmaceuticals Customer Support at 1-800-616-2471, Option #1 available Monday through Friday 8 a.m. – 8 p.m. EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

This recall is being conducted with the full knowledge of the U.S. FDA.

MAJOR PHARMACEUTICALS

Product DescriptionNDC NumberItem NumberLot NumberExpiration Date
Valsartan 80mg Tablets, USP0904-6594-61302086T0179505/2019
T0180705/2019
T0171202/2019
T0162502/2019
T0159602/2019
T0150002/2019
T0146607/2018
T0127007/2018
Valsartan 160mg Tablets, USP00904-6595-61302087T0164605/2019
T0178805/2019
T0166805/2019
T0152402/2019
T0126907/2018

FDA Press Announcement

 

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Product Photos

  • Product packaging image Major Pharmaceuticals Valsartan Tablets, USP 80 mg 
  • Product packaging image Major Pharmaceuticals Valsartan Tablets, USP 160 mg 

Page Last Updated: 07/16/2018
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