Earlier this month both the European Union (EU) and the US announced plans to recall products containing valsartan manufactured by Chinese active pharmaceutical ingredient (API) producer Zhejiang Hauhai.
China’s National Health and Family Planning Commission has since followed suit, by issuing a nationwide recall and advised medical institutions (link in Mandarin) to no longer use the products.
The action was taken after impurities were found to have been introduced during the production process of the ingredient, with probable carcinogen N-nitrosodimethylamine (NDMA) discovered during analysis.
The European Medicines Agency (EMA) concluded that the contamination was likely to have come about due to changes in the manufacturing process enacted in 2012, which the (EMA stated may have been instrumental in producing NDMA as ‘a side product’.
According to China’s Food and Drug Administration, both the US Food and Drug Administration (FDA) and the EMA had approved Zhejiang Hauhai production methods for valsartan, in 2012 and 2013, respectively.
The manufacturing issue come at a particularly bad time for China’s life science sector, as a vaccine scandal has claimed a number of headline across the world.
Changsheng Biotechnlogy has been found to fake records to speed up the production of its rabies vaccine. The behaviour led to sharp recriminations from China’s Premier, Li Keqiang, amid a public backlash due to the substandard vaccines being administered to children.