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Mylan expands recall for blood pressure drug valsartan

By
Sommer Brokaw
Mylan on Tuesday expanded its recall for valsartan due to potential contamination. File Photo by ronstik/Shutterstock/UPI
Mylan on Tuesday expanded its recall for valsartan due to potential contamination. File Photo by ronstik/Shutterstock/UPI

Dec. 4 (UPI) -- U.S.-based Mylan Pharmaceuticals said Tuesday it's recalling all of its valsartan blood pressure medicine due to a potentially cancer-causing impurity.

The recall of 104 additional lots includes amlodipine, hydrochlorothiazide and valsartan tablets "out of an abundance of caution," a company statement said, "due to detected trace amounts of an impurity."

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Mylan said the impurity, N-nitrosodiethylamine (NDEA) "is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer."

The recalled batches were distributed in the United States between March 2017 and November 2018.

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The voluntary nationwide recall of all valsartan expands on a more limited recall two weeks ago.

The Food and Drug Administration has urged patients to consult their physicians before discontinuing use of the drug, even those subject to recall.

The FDA first recalled valsartan in July after the Chinese company that makes the drugs, Zhejiang Huahai Pharmaceuticals, found N-nitrosodimethylamine (NDMA) in batches of its active ingredient, valsartan API. In September, the FDA said certain Torrent valsartan lots were also tainted with NDEA, classified as a possible cancer-causing agent by the U.S. Environmental Protection Agency.

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Since then, the list of hypertension drugs voluntarily recalled over either NDEA or NDMA contamination has grown to include other brands including losartan, amlopidine, irbesartan and hydrochlorothiazide.

Mylan, also a brand-maker of the emergency allergy EpiPen injector, has previously been criticized for increasing the EpiPen's cost 548 percent over a decade, resulting in a $600 cost for a two-pack.

Mylan's half-price version of the EpiPen was introduced in 2016 -- and Teva Pharmaceutical last week introduced a generic version for the same price as Mylan's.

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