LONDON (Reuters) – Heart drugs containing an active ingredient from a second Chinese company are being recalled from the European market after detection of a toxic impurity that may cause cancer.
The European Medicines Agency said on Monday that Zhejiang Tianyu Pharmaceutical was no longer authorized to manufacture valsartan for EU medicines and a certificate verifying the quality of its product had been suspended.
Both the medicines agency and the Chinese company said valsartan-containing drugs produced by Zhejiang Tianyu were now being recalled.
The EMA had already announced on Aug. 10 that some batches of valsartan supplied by Zhejiang Tianyu had been found to contain N-nitrosodimethylamine or NDMA, a probable human carcinogen.
However, the levels of NDMA found in Zhejiang Tianyu’s supplies were considerably lower than those detected in valsartan from Zhejiang Huahai Pharmaceutical, the agency said.
News of the contamination in Zhejiang Huahai’s valsartan active ingredient triggered a global alert last month.
(Reporting by Ben Hirschler, editing by Louise Heavens)