China's national drug watchdog on Tuesday cited substandard
disinfection as a major factor leading to the lethality of a
suspect antibiotic injection, which has allegedly killed six
people.
The "Xinfu" drug manufactured in June and July by Anhui Huayuan
Worldbest Biology Pharmacy Co. wasn't sterilized properly, with
both the sterilization temperature and time below the
state-required safety level, said China's State Food and Drug
Administration (SFDA).
"As required, the drug should go through a 30-minute
disinfection process at 105 degrees Celsius. But the company
lowered the temperature to 100 to 104 degrees Celsius and shortened
the time to only one to four minutes," said Wang Zhexiong, an
official with the safety supervision department of the SFDA.
Disinfection cabinets were also overloaded with the injection,
and thus could not effectively wipe out bacteria,Wang said.
The administration promised to punish the company for its
production faults and held related producers and managers
accountable, but gave no details.
The administration has sent out an investigation team to inspect
the pharmaceutical company in East China's Anhui Province. Test on
the injection sample conducted by the team has detected excessive
bacteria.
Wang said further analysis is needed to find out what kinds of
bacteria the sample contains.
Earlier investigation results 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.
So far, more than 1.2 million bottles of the drug had been
recalled, 173,007 were en route back to the factory, and more than
403,170 bottles had been located and sealed up in other areas, said
Zhang Jixiang, the administration's spokesman.
He could not account for the whereabouts of the remainder of the
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 10 provinces including Zhejiang, Heilongjiang, Hunan
and Shandong.
(Xinhua News Agency August 15, 2006)