LYNCHBURG, Va. (WSET) - The U.S. Food and Drug Administration has alerted health care professionals and patients who take medication for high blood pressure and heart failure about a new recall.
The recall involves drugs that contain the ingredient valsartan.
Valsartan is used to treat high blood pressure and heart failure, according to the FDA.
It wrote that an impurity has been found in valsartan called N-nitrosodimethylamine (NDMA).
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
NDMA is classified as a probable human carcinogen based on lab tests.
Retail pharmacies in possession of any unused products including Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiry dates from July 2018 to January 2020, should immediately return the product.
The FDA believes the sudden presence of NDMA is because of the way the substance was manufactured.
Some of the companies recalling the medications include Major Pharmeceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.