FDA Recalls Drugs Containing Active Ingredient Valsartan

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All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled.
All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled.

(HealthDay News) -- Several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure, are being recalled due to an impurity, N-nitrosodimethylamine, that has been found in the recalled products, according to the US Food and Drug Administration.

Patients taking the recalled valsartan-containing medications should continue taking them until they have a replacement product. Patients should look at the drug name and company name on the label of their prescription bottle to determine whether a specific product has been recalled. The recall instructions provided by the specific company should be followed if a patient is taking one of the recalled medications listed. Patients should also contact their health care professional to discuss their treatment.

Companies are recalling all lots of non-expired products that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals. The products that are being recalled include valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries, and valsartan/hydrochlorothiazide from Solco Healthcare and Teva Pharmaceuticals Industries.

"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," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "This is why we've asked these companies to take immediate action to protect patients."

Reference

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. FDA; July 13, 2018.

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