Second Chinese Pharma Included in Valsartan Recall
As part of the ongoing review of valsartan medicines, The European Medicines Agency (EMA) has learned that low levels of N-nitrosodimethylamine (NDMA) have been detected in the valsartan active substance manufactured by a second Chinese company, Zhejiang Tianyu Pharma.
According to the EMA, there is no immediate risk to patients. Patients should not stop taking any valsartan medicines without consulting their doctor or pharmacist.
A list of medicines containing valsartan from Zhejiang Tianyu will be available from national medicines authorities.
Zhejiang Tianyu Pharmaceutical Co., Ltd. is a specialized researching, developing and manufacturing enterprise of active pharmaceutical ingredients (API) and pharmaceutical intermediates. At present, Tianyu is a “hi-tech “enterprise authenticated by China and Zhejiang province and one of “top-10 enterprise” of Huangyan region.
More than 20 European countries, Canada, and the United States have recalled valsartan medications in recent weeks after NDMA was discovered in the API manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China.
The EMA said the NDMA levels detected in batches of valsartan from Zhejiang Tianyu are much lower than levels seen in the active substance from Zhejiang Huahai.
EMA is working closely with international partners to review the impact of the NDMA detected in valsartan from Zhejiang Tianyu and will communicate as soon as additional information becomes available.
NDMA is classified as a substance that could cause cancer, based on results from laboratory tests.
The European Medicines Agency is a decentralized agency of the European Union (EU) and is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
Previously, on August 9th, 2018, the ongoing Food and Drug Administration (FDA) product recall of valsartan-containing products was expanded to include Camber Pharmaceuticals brands.
This FDA update incorporates recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc.
But, this FDA recall does not include every Camber valsartan product distributed in the USA.