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Production faults are being held responsible by China's State Food and Drug Administration (SFDA) for a suspect antibiotic injection which has allegedly caused the deaths of six people.
An SFDA spokesman said production of the "Xinfu" drug, manufactured by Anhui Huayuan Worldbest Biology Pharmacy Co., a subsidiary of Shanghai Worldbest Co. Ltd., failed to meet the required technical procedures.
An investigative team has inspected the pharmaceutical company in east China's Anhui Province and checked the procedures applied in June and July when the faulty drug was produced.
The production records of the company were incomplete, said the spokesman, adding that investigations were continuing into the link between the patient reactions and the antibiotic injection.
The spokesman said investigations showed the company had produced 3.7 million bottles of clindamycin phosphate glucose injection since June with more than 3.18 million bottles sold in 26 provinces across China.
More than 755,000 bottles of the drug had been recalled, 185,500 were on their way back to the factory and more than 161,200 had been located and isolated in other areas, he said.
He could not account for the whereabouts of the remaining bottles only saying it was likely they were scattered in small hospitals, clinics and drugstores in remote areas where it was difficult to find them.
The spokesman said the drug had been removed from use as it was a prescription medicine and the Ministry of Health had banned it after reports of problems so the situation was under control.
Pan Wei, vice manager in charge of production in the pharmacy company, told Xinhua that the temperature and time for disinfections during the production was not in accordance with the requirements.
The injection should be kept and transported in a cool environment according to the regulation. "But we couldn't ensure that the medicines were transported under the required 20 Celsius degrees," Pan said.
At another press conference on Thursday, Vice Minister of Health Jiang Zuojun said investigators were still waiting for the result of index for bacteria of the drug.
Since the first reports of the problem injections on July 27 the drug is being blamed for the deaths of six people and causing illness to at least 80 others in ten provinces including Zhejiang, Heilongjiang, Hunan and Shandong.
Severe adverse reactions were reported among some patients after taking the drug. These include chest, kidney and stomach pains, vomiting and anaphylactic shock.
The Ministry of Health has demanded that all provincial health departments report cases of adverse reactions to the drug by 4 PM each day.
Two months earlier, a fake injection produced by the Qiqihar No.2 Pharmaceutical Co. Ltd., a privately-owned business in northeast China's Heilongjiang Province, caused 11 deaths.
Both of the companies in these two cases are qualified pharmaceutical firms and the medicines produced by them are sold onto the market through normal channels. This fact makes the Chinese public worry about the safety of medicines and supervision of production facilities.
Zhao Xueming, head of the Association for Medical Workers in Heilongjiang, said that the two cases showed loopholes in China's drug administration. He said China's drug administration department should strengthen supervision and law enforcement in the production, circulation and use of medicines.
(Xinhua News Agency August 11, 2006)
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