It's been concluded by investigators that the deaths blamed on
the use of an antibiotic were caused by "substandard disinfection"
during the manufacturing process, the State Food and Drug
Administration (SFDA) said yesterday.
SFDA has punished those responsible for the mistakes, Xinhua
News Agency said, without identifying them or saying what penalties
were handed out.?
According to the results of the investigation the drug wasn't
sterilized properly with both the sterilization temperature and
duration below the state standard, said SFDA.
"The drug should go through a 30-minute disinfection process at
105°C but the company lowered the temperature to 100-104°C and
shortened the time to only one to four minutes," said Wang
Zhexiong, an official with SFDA's safety supervision
department.
Disinfection cabinets were also overloaded and thus could not
effectively destroy any bacteria, Wang added.
Last month the government ordered a recall of batches of the
drug made by Huayuan Worldbest Biology Pharmacy Co Ltd in east
China's Anhui Province after a six-year-old girl died.
SFDA later blamed the drug, clindamycin phosphate glucose, for at
least five other deaths.
Media reports said at least 10 people died after receiving the
drug, which is used to treat bacterial infections.
Approximately 80 patients in 10 provinces including Zhejiang, Heilongjiang, Hunan and Shandong who received the drug suffered
symptoms ranging from diarrhea and nausea to kidney pains and
shock, according to reports.
Investigators earlier said they were looking into possible
bacterial contamination of the drug, ruling out other factors.
Tests done by the SFDA team at the company detected excessive
bacteria. Wang said further analysis was needed to discover what
types of bacteria the sample contained.
The company produced 3.7 million bottles of the drug since June
with more than 3.18 million having been sold in 26 provinces. So
far more than 1.2 million bottles have been recalled, 173,000 are
on their way back to the factory and more than 403,000 located and
sealed, said Zhang Jixiang, SFDA's spokesman.
Sun Lei, an official in charge of market supervision with SFDA,
said the remaining bottles might have been used or scattered in
hospitals, clinics and drugstores in small cities and remote rural
areas, making them difficult to retrieve. SFDA will continue to
"comb every corner" and "trace every single bottle," he said.
Shao Mingli, SFDA's director, said yesterday that the incident
exposed a lack of proper controls in the drug market and loopholes
in supervision. SFDA, along with other departments, will soon
launch a one-year national campaign to regulate the drug
market.
(China Daily August 16, 2006)