The Food and Drug Administration (FDA) is issuing a worldwide recall for a blood pressure and heart failure medication that contains an active ingredient linked to an impurity that is a known probable human carcinogen.
The agency announced a preliminary recall last month but has expanded the list of products that contain valsartan and the suspected impurity, the carcinogen N-nitrosodimethylamine (NDMA). “The presence of NDMA was unexpected and is thought to be related to changes in the way [valsartan] was manufactured,” the FDA said in a statement.
The full FDA recall list is available here.
Tablets containing valsartan and distributed by the following drug companies are being recalled:
- A-S Medication Solutions
- Bryant Ranch Prepack Inc.
- H. J. Harkins Company
- Prinston (labeled as Solco Healthcare LLC)
- Proficient Rx LP
- Remedy Repack
- Teva (labeled as Actavis and as Major Pharmaceuticals)
While the review is ongoing, the FDA has also issued a list of products containing valsartan that are NOT subject to the recall. That list can also be found at the FDA website.
The FDA advised that “patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.” If their medicine is part of the recall, the agency urged, patients “should contact their health care professional . . . to discuss their treatment.”
The Chinese supplier of the valsartan in the affected drugs, Zhejiang Huahai Pharmaceuticals, “has stopped distributing” the active ingredient “and the FDA is working with the affected companies” to eliminate the NDMA presence, the agency said in a statement.