Blood drug recalled for 'violations'

By Qiu Quanlin (China Daily)
Updated: 2007-01-24 07:26

GUANGZHOU: 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".

"We will be keeping a close watch on the sale and use of these blood products in drug stores and hospitals following the release of the notice," Yu Dewen, a spokesman for the Guangdong Provincial Health Department, said in an interview with China Daily yesterday.

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.

Huang Sui, an official with the Guangzhou Health Bureau, said all hospitals in Guangdong's capital city had withdrawn the drug.

"We are also asking hospitals to keep records of patients who have been treated with the drug," Huang said.

Meanwhile, health authorities in Shanghai collected 4,832 bottles of the drug, the Shanghai-based News Evening reported yesterday.

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, sources with the company's official website said.

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.

Sources with the company's website said the company had developed a large sales network stretching across the nation.

"So we are working with health authorities in other regions to deal with the suspension of the company's drugs," Yu said.

Officials from the company refused to be interviewed yesterday.

(China Daily 01/24/2007 page4)

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