COMPANY ANNOUNCEMENT
Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to the Potential Presence of a Probable Carcinogen (NDMA)
This recall has been completed and FDA has terminated this recall.
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.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
Generic Drugs - Reason for Announcement:
-
Recall Reason Descriptionmay contain the probable carcinogen Nnitrosodimethylamine (NDMA)
- Company Name:
- Major Pharmaceuticals
- Brand Name:
-
Brand Name(s)Major Pharmaceuticals
- Product Description:
-
Product DescriptionValsartan 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.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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 |
Company Contact Information
- Consumers:
- Major Pharmaceuticals Customer Support
- 1-800-616-2471
- Media:
- Ellen Barry
- (614) 553-3858
- ellen.barry@cardinalhealth.com
