Blood Pressure, Heart Failure Medication Recalled by FDA


Monday, July 16th 2018, 11:34 am
By: News 9


The U.S. Food and Drug Administration is issuing a voluntary recall of several drug products used to treat high blood pressure and heart failure.

The recall is due to an impurity N-nitrosodimethylaminewhich (NDMA) was found in the recalled products.

Not all products containing valsartan are being recalled, however. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, according to the FDA.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

Recalled products include Valsartan sold by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. and Valsartan/Hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.