Doctors and their patients are warned to check their medications containing the ingredient valsartan as they might have been manufactured incorrectly.
The Food and Drug Administration has issued a voluntarily recall of high blood pressure and heart failure drugs following the discovery of an impurity, called N-nitrosodimethylamine (NDMA), in those products, according to a news release.
Not all valsartan-containing medications are being recalled, however.
Officials say NDMA is a probable human carcinogen, or something that could cause cancer, and is believed to be related to how the products were manufactured.
The recalled products include:
-Valsartan, manufactured by Major Pharmaceuticals
-Valsartan, manufactured by Solco Healthcare
-Valsartan, manufactured by Teva Pharmaceuticals Industries Ltd.
-Valsartan/Hydrochlorothiazide (HCTZ), manufactured by Solco Healthcare
-Valsartan/Hydrochlorothiazide (HCTZ), manufactured by Teva Pharmaceuticals Industries Ltd.
Health care officials and patients are advised to continue taking the affected medicines because valsartan is used to treat serious conditions. However, they should switch once a replacement product becomes available.
More information will be posted on the FDA's website.
"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," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in the release.
"This is why we’ve asked these companies to take immediate action to protect patients."
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