China's national drug watchdog said yesterday that all suspect "Xinfu" antibiotic injections, which have allegedly caused six deaths in the country, must be recalled by August 31.
The State Food and Drug Administration instructed the drug's manufacturer, Anhui Huayuan Worldbest Biology Pharmacy Co, to retrieve all "Xinfu" drugs it produced in June and July before that date.
The administration demanded that all provincial drug departments strengthen supervision of recall work within their jurisdictions and tighten checks on hospitals, clinics and pharmacists.
The administration has discovered that the problematic injection was not properly sterilized with both length of sterilization time and temperature below the state-required safety level.
After initial reports about problems with the injection came on July 27, the drug has been linked to the deaths of six people; it was also blamed for making at least 80 others unwell. Severe adverse reactions to the medication have included chest, kidney or stomach pains, vomiting and anaphylactic shock.
"Xinfu" produced before June can still be used, the administration said, but local departments should be vigilant about adverse reactions.
Earlier investigation results showed the manufacturer had produced 3.7 million bottles of the drug 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 medication have been returned, 173,000 are on their way back to the factory and 403,170 have been located and sealed up in other areas.
The remaining bottles may have been used or are scattered in hospitals, clinics and drugstores in small cities and remote rural areas, making them difficult to retrieve, according to the administration.
(China Daily August 18, 2006)