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PTI Hyderabad
Updated: 19-12-2018 15:22 IST

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


"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.

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


"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


"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.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)