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Mylan to Recall All Batches of Blood Pressure Medicine Valsartan in U.S.

December 04, 2018

By Reuters Staff

(Reuters) - Mylan NV said on Tuesday it is expanding a nationwide voluntary recall of its blood pressure medicine valsartan to include all lots, two weeks after it recalled select batches.

The drugmaker said it was recalling 104 additional lots "out of an abundance of caution" after the valsartan-containing products were found to contain traces of a probable cancer-causing impurity.

Several drugmakers, including Teva Pharmaceutical Industries Ltd, have recalled batches of valsartan and drugs containing the substance that are suspected to be tainted with probable carcinogens N-nitrosodiethylamine (NDEA)and N-nitrosodimethylamine (NDMA).

Global health authorities have also clamped down, with European regulators last month effectively banning sales of the product, made by Mylan's India-based unit, in Europe.

The finished products recalled by Mylan on Tuesday, were manufactured by its units Mylan Pharmaceuticals Inc and India-based Mylan Laboratories Ltd and distributed in the United States between March 2017 and November 2018, the company said in a statement.

Leerink analyst Ami Fadia said the recall should not affect the company's forecast for the year.

"It is not a very big product for the company," she said.

Still, Mylan's shares fell 2.6 percent to $33.18 in mid-day trade.

The U.S. Food and Drug Administration had earlier halted imports of drug ingredients or medicines containing ingredients produced at a factory belonging to a Chinese bulk manufacturer of valsartan, Zhejiang Huahai Pharmaceuticals.

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