Drug major Mylan has said it was voluntarily recalling over 1.2 million bottles of three anti-hypertension drugs of different count from the US market due to the presence of an impurity, N-nitrosodiethylamine (NDEA), which is believed to cause cancer. According to the notification put up by US Food and Drug Administration (FDA), Valsartan, the Active Pharma Ingredient in all the three drugs, Amlodipine and Valsartan, Valsartan and Valsartan and Hydrochlorothiazide Tablets, was manufactured by Mylan Laboratories Limited in its Nashik plant.
“Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. 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 (IARC),” Mylan said in its letter to the FDA on December 4.
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The company said it has initiated the recalling of certain batches of the three drugs with various strengths. The finished products were manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. And these batches were distributed in the US between March 2017 and November 2018, Mylan said. Valsartan is used for the treatment of high blood pressure for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. Valsartan in combination with amlodipine or hydrochlorothiazide is used for the treatment of high blood pressure.
“Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products,” Mylan said. On November 19, European Medicines Agency said national authorities in the Europen Union started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination. “Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India,” EMA had said.