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Valsartan recall expanded to include all of one company’s products

Valsartan recall expanded to include all of one company’s products
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(RNN) – A recall that has affected batches of valsartan, a widely-used blood pressure drug made by the pharmaceutical company Mylan, expanded on Wednesday to include all of the company’s valsartan-containing products.

An earlier recall last month affected a number of its valsartan products.

The expanded recall has been issued by the Food and Drug Administration because of an impurity found in the drugs known as NDEA. The compound, according to the FDA, is considered cancer-causing.

“NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial process, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer,” an FDA release stated.

Trace amounts of the impurity have been linked to other recalls of valsartan products affecting other companies in the last few months.

The FDA advises patients using Mylan valsartan products to continue to take them until an alternative medication can be arranged.

“The risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the FDA release said. 

A full list of valsartan products under recall is available at the FDA website.

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