cracks down on blood pressure medicine made by Mylan
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[November 20, 2018]
(Reuters) - European Union authorities on
Monday stepped in to effectively ban sales of blood pressure medicine
valsartan made by an India-based unit of Mylan NV after some batches
were found to contain a probable cancer-causing impurity, the latest in
a global crackdown.
The European regulator said the unit's compliance certificate had
been suspended, effectively prohibiting the use of its valsartan in
medicines in the region.
The affected batches are being recalled and tests conducted to
determine the extent of the contamination, the European Medicines
The batches were found to contain N-nitrosodiethylamine (NDEA), a
probable carcinogen, and were made in Mylan's Hyderabad facility in
India, the EMA said.
Cancer-causing impurities have been linked to batches of valsartan
over the past year, leading to a global recall.
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The U.S. Food and Drug Administration last month halted imports of
drug ingredients or medicines made with ingredients produced at a
factory belonging to a Chinese bulk manufacturer of valsartan,
Zhejiang Huahai Pharmaceuticals.
Huahai has recalled valsartan products made at its factory in
China's Chuannan province after N-nitrosodimethylamine (NDMA),
another impurity linked to cancer, was found.
Mylan did not immediately respond to a request for comment.
(Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel)
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