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
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,"
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.)