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Mylan recalls 1.2 million bottles of 'made in India' BP drug from US

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products

Press Trust of India  |  Hyderabad 

Torrent Pharma, Pharma

Drug has said it was voluntarily recalling over 1.2 million bottles of three anti-drugs of different count from the US market due to the presence of an impurity, (NDEA), which is believed to cause

According to the notification put up by (FDA), Valsartan, the Active Pharma Ingredient in all the three drugs, Amlodipine and Valsartan, and and Hydrochlorothiazide Tablets, was manufactured by Laboratories Limited in its

"Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, (NDEA) contained in the API Valsartan, USP, manufactured by 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 on (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

The finished products were manufactured by Inc. and

And these batches were distributed in the US between March 2017 and November 2018, Mylan said.

is used for the for the treatment of heart failure, and to reduce cardiovascular mortality following

Valsartan in combination with amlodipine or hydrochlorothiazide is used for the

"Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products," Mylan said.

On November 19, said national authorities in the 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, (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India," EMA had said.

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First Published: Wed, December 19 2018. 15:25 IST