Category: CVS drug
Indication: used to treat high blood pressure and heart failure
Present status: Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines supplied by various companies.
Why this Recall?
It was found that valsartan medicines from a Chinese manufacturer, Zhejiang Huahai Pharmaceuticals, were containing N-nitrosodimethylamine (NDMA), that poses a potential cancer risk.
N-nitrosodimethylamine or NDMA, is classified as a probable human carcinogen, based on results from lab tests.
How this case revealed?
Timeline of the events
July 5th – The European Medicines Agency (EMA) first raised the potential cancer risk from the Chinese supplied valsartan on July 5 and began recalling medicines containing valsartan from Zhejiang Huahai.
14th of July – U.S. Food and Drug Administration also took action to recall affected valsartan-containing medicines.
Slowly all regulatory body across different region and countries started red alert for valsartan.—-
The regulatory agency noted that not all valsartan medicines for high blood pressure or heart failure are being recalled, only the affected brands. The recalled products include valsartan distributed by: Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. It also includes valsartan/hydrochlorothiazide formulations distributed by Solco Healthcare and Teva.
The FDA added, “Zhejiang Huahai has stopped distributing its valsartan API [active pharmaceutical ingredient], and the FDA is working with the affected companies to reduce or eliminate the impurity from future products.”