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  4. Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

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

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.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
may contain the probable carcinogen Nnitrosodimethylamine (NDMA)
Company Name:
Major Pharmaceuticals
Brand Name:
Brand Name(s)
Major Pharmaceuticals
Product Description:
Product Description
Valsartan tablets, 80mg USP and 160 mg USP

Company 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 Description NDC Number Item Number Lot Number Expiration Date
Valsartan 80mg Tablets, USP 0904-6594-61 302086 T01795 05/2019
T01807 05/2019
T01712 02/2019
T01625 02/2019
T01596 02/2019
T01500 02/2019
T01466 07/2018
T01270 07/2018
Valsartan 160mg Tablets, USP 00904-6595-61 302087 T01646 05/2019
T01788 05/2019
T01668 05/2019
T01524 02/2019
T01269 07/2018

FDA Press Announcement  


Company Contact Information

Consumers:
Major Pharmaceuticals Customer Support
1-800-616-2471
Media:
Ellen Barry
(614) 553-3858
ellen.barry@cardinalhealth.com

Product Photos