Recall rabies vaccine of a batch of questions voluntarily in Wuhan Have already used the shares of 8376 people

Recall rabies vaccine of a batch of questions voluntarily in Wuhan Have already used the shares of 8376 people
Recall rabies vaccine of a batch of questions voluntarily in Wuhan Have already used the shares of 8376 people
Beijing, May 25 (Xinhuanet) ' Reporter Cui Jing) The reporter learns from the national food medicines supervision bureau on the 25th, because a batch of " freeze and be a person and use vaccine of rabies " Perhaps the quality risk exists, the institute of biological products of Wuhan determines to recall this batch of vaccine voluntarily. Report, the lot number of its production is for " freeze and do to people and use vaccine of rabies (Vero cells)ing of 200905007- 3 according to the institute of biological products of Wuhan " The endotoxin of bacterium goes beyond the standard to stipulate, apt to cause generating heat to reflect after using. Use safely for the person who guarantees vaccine inoculation, the institute of biological products of Wuhan determines to recall this batch of products, should already establish the specialized agency to be responsible for handling the matters relevantly at present. The report of supervision bureau of Hubei food medicines reveals, this batch of vaccine that the institute of biological products of Wuhan produces sells 10902 people one altogether, by 24 o'clock on May 24, this batch of products have already all investigated, 2526 people one among them has already been recalled or controlled use, in 8376 people one that has already used, have not received the bad reaction report yet. The national food medicines supervision bureau says, the pharmaceuticals administration department, according to the relevant regulations of " medicines recall management ", supervise this time recalling, working, pay close attention to to this, supervise and inspect, once the medicines finding illegality in violation of rules and regulations produce the behavior, will deal with in accordance with the law. It is reported, the endotoxin of bacterium is a material existing in the auxiliary materials of Central Plains of production process, demand to control in production in the fixed range. Main chemical composition its lipopolysaccharide, the intersection of leather and getting blue characterized structure at the negative bacterium's cell wall, the endotoxin is caused hotly originally for the other source, it causes the human body to generate heat in short-term to exceed a certain amount to know. Recall the relevant regulations of management according to medicines of our country, the medicines manufacturing enterprise should set up and improve medicines and recall the system, collect the safe relevant information of medicines, medicines to having the potential safety hazard most probably carry on the investigation assessment, find there is potential safety hazard in medicines, should recall voluntarily.


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