The product contains a trace amount of an unexpected impurity
of ConsumerAffairs
Major Pharmaceuticals is recalling all lots Valsartan which was supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals and is used to treat hypertension (high blood pressure) and heart failure.
Trace amounts of an unexpected impurity -- N- nitrosodimethylamine (NDMA -- were found in an active pharmaceutical ingredient (API).
NDMA has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
The following product, distributed nationwide as unit dose blisters with 100 tablets per carton, is being recalled:
| 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 |
What to do
Consumers with questions regarding the recall may contact Major Pharmaceuticals customer support at (800) 616-2471, Option #1 Monday through Friday, 8 a.m. 8 p.m. (EST).