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Human Blood Products Recalled
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Health authorities in south China's Guangdong Province have called on drugstores 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'll be keeping a close watch on the sale and use of these blood products in drugstores 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 drugstores in the city to stop selling and administering the drug after patients who'd been treated with it reportedly suffered from "negative effects".

The SFDA's notice didn't say how the Guangdong-based company had violated drug rules or what the "negative effects" resulting from the drug's use were.

Huang Sui, an official with the Guangzhou Health Bureau, said all hospitals in Guangdong's capital city had withdrawn the drug. "We're also asking hospitals to keep records of patients who've been treated with the drug," Huang said.

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

The Guangdong Bioyee company is based in Guangdong's northern city of Shaoguan. The SFDA granted the company a certificate for good manufacturing products (GMP) for pharmaceutical items on November 24 last year, 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 blacklist in August last year for illegally collecting human blood.

The company's website said they'd developed a large sales network stretching across the country.

"So we're 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 January 24, 2007)

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