A mother-and-daughter team allegedly behind a massive illegal sale of vaccines in Shandong province are under arrest as the China FDA moves to track down the potentially harmful supplies by calling for immediate help from manufacturers and distributors.
State-run news agency Xinhua reports that RMB570 million ($88 million) of vaccines sold illegally are in the market and even though manufactured under license could be of questionable quality under poor supply chain handling.
In official notices on Sunday, CFDA told manufacturers and distribution companies to come up with a detailed picture of where the supplies landed by the end of the week, March 25.
In a separate notice, the Shandong FDA said the items covered under the recall are 12 vaccines, 2 immune globulin products and one therapeutic product.
Earlier reports said the suspects allegedly purchased 25 types of vaccines from more than 100 pharmaceutical salesmen, both licensed and unlicensed, and sold them to "illegal agents" or even local disease control and prevention centers at high prices, according to Xinhua.
One of two China FDA notices on the case identified the issue as "criminal acts" and ordered unspecified companies to help public security investigators to identify the "variety, quantity, batch number, and the flow of buying and selling the vaccines" in the probe or face "serious punishment."
Late last month, China FDA Commissioner Bi Jingquan said the regulator was aiming for the "most stringent" standards" for food, drug and device safety along with the "most severe punishment" for fraud.
After the chemical the chemical melamine was found in local infant formula brands in 2007 that caused infant deaths and serious illness for many children, China executed the top food and drug regulator at the time, Zheng Xiaoyu, for his role in the scandal.
In the past few years, China has moved to bolster local manufacturing efforts for vaccines used domestically as well as prequalification by the World Health Organization in global campaigns.
- here's the China FDA first notice (Chinese language)
- and a second China FDA notice on investigation (Chinese language)
- and a story on the investigation from a Xinhua report carried by Shanghai Daily
- here's a list of vaccines, products from Shandong FDA (Chinese language)