A notice on the website of China's State Food and Drug Administration (SFDA) said on Monday that an initial inspection of samples of a human antibody injection that has been linked to six deaths confirmed there were some abnormalities.
Test results from the National Institute for the Control of Pharmaceutical and Biological Products show that the drugs produced by Jiangxi Yabo Bio-pharmaceutical Co., (JYBC) do not measure up to existing standards, the drug regulator's statement said.
Six people died after being injected with the immune globulin from May 22 to 28 at the No.2 Hospital Affiliated with Nanchang University in eastern China's Jiangxi Province. All of the drugs were produced by Jiangxi Yabo Bio-pharmaceutical Co. and had the same batch number.
The State Food and Drug Administration and the Health Ministry ordered the company to suspend sales last week and recall the batch of immune globulin.
Local authorities sealed all JYBC human immune globulin and took samples for testing in the National Institute for the Control of Pharmaceutical and Biological Products.
The Jiangxi public security authorities were also looking into the case.
No details about the victims and the dates of their deaths are available so far and adverse drug reactions related to the same batch of drugs have not been reported elsewhere, Xinhua news agency reported Monday.
Immune globulin is an antibody extracted from blood plasma that can be injected into muscles to protect against hepatitis A, and Rhesus disease in pregnant women.
(CRIENGLISH.com June 3, 2008)