FDA Recalls Heart Medications Containing the Active Ingredient Valsartan

FDA Recalls Heart Medications Containing the Active Ingredient Valsartan

FDA Recalls Heart Medications Containing the Active Ingredient Valsartan

The development comes following indications of the presence of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active pharmaceutical substance supplied by Chinese company Zhejiang Huahai Pharmaceuticals and used in these prescription medications.

In Europe and Asia, Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled because they "do not meet our high quality standards".

To determine if a specific product has been recalled, look at the drug name and company name on the prescription bottle's label.

Also, you should contact your doctor of whoever the pharmacists was that dispensed the impacted drugs to you to discuss an alternative option. Solco and Teva were also asked to recall their drugs containing valsartan/hydrochlorothiazide (HCTZ). Major Pharmaceuticals as a distribution firm, is recalling all lots within expiry of Valsartan supplied by Teva Pharmaceuticals. Also, the FDA said there is a link between valsartan and cancer. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

The FDA will continue to investigate this issue and provide additional information when it becomes available.

The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies.

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FDA is spending time in reviewing the drug and in the meantime, three companies which are based in the U.S. has refused to sell the medications which are containing valsartan. "This is why we've asked these companies to take immediate action to protect patients", Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said.

The list of recalled products includes Cinfaval and Co-cinfaval manufactured by Spanish Cinfa Laboratories, as well as Diostar and Diostar plus manufactured by Jordan's Pharma International Co.

According to Scott Gottlieb, the FDA commissioner "The FDA is committed to maintaining our gold standard for safety and efficacy".

Dr. Harry Lever, a cardiologist at the Cleveland Clinic, said he was concerned about quality control of generic medicines, like valsartan, made in China and India.

"It's not just valsartan", Lever said.

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