Blood drug recalled for 'violations'

   Date:2007/01/24

Health authorities in South China's Guangdong Province have called on drug stores and hospitals to withdraw potentially unsafe human-blood products made by a local pharmaceutical company. The call came after a notice jointly issued by the Ministry of Health and the State Food and Drug Administration (SFDA) early on Sunday indicated that Guangdong Bioyee Pharmaceutical Co Ltd had "seriously" violated drug manufacturing rules in producing an intravenously injected blood drug called "human-blood gamma globulin".

Prior to the release of the SFDA's notice, the Beijing health bureau had asked hospitals and drug stores in the city to stop selling and administering the drug after patients who had been treated with it reportedly suffered from "negative effects".

The SFDA's notice did not say how the Guangdong-based company had violated drug rules or what "negative effects" resulted from the drug's use.

Guangdong Bioyee Pharmaceutical Co Ltd is based in Guangdong's northern city of Shaoguan. The SFDA granted the company a certificate for good manufacturing products (GMP) for pharmaceutical goods on November 24 last year.

However, the SFDA canceled the company's GMP certificate on January 16 for serious violations of drug-manufacturing regulations. The company also appeared on a black list in August last year for illegally collecting human blood.

The company had developed a large sales network stretching across the nation.

 

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