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21 Jul 2018

Case Study: Global Recall of Valsartan due to it’s impurity that is carcinogenic

Molecule: Valsartan
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.

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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.

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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.

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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.”

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