China’s State Food and Drug Administration (SFDA) on Thursday blamed production faults for a suspect antibiotic injection that has allegedly killed 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 required technical procedures.
An investigation team has inspected the pharmaceutical company in east China’s Anhui Province and checked the procedures applied in June and July when the 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 en route back to the factory, and more than 161,200 bottles had been located and isolated in other areas, he said.
He could not account for the whereabouts of the remainder of the drug, only saying it was scattered in small hospitals, clinics and drugstores in the remote areas, where it was difficult to retrieve.
He 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 basically 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 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 here on Thursday, Vice Minister of Health Jiang Zuojun said investigators are still waiting for the result of index for bacteria of the problematic drug.
Since the first report of the problematic injection on July 27, the drug is blamed for killing six and causing illness to at least 80 people in ten provinces including Zhejiang, Heilongjiang, Hunan and Shandong.
Severe adverse reactions were reported among patients after taking the drug, such as chest, kidney or stomach pains, vomiting and anaphylactic shock.
The Ministry of Health has demanded that all provincial health departments report cases of adverse reactions to the problematic drug by 4 p.m. 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 in China.
Both of the companies in the two accidents are qualified pharmaceutical companies and the medicines produced by the two firms were sold to market through legal channels. The fact makes Chinese public worry about the safety of medicine and supervision of the medicine market.
Zhao Xueming, head of the Association for Medical Workers in Heilongjiang, said that the two accidents show the loophole 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.