Watchdog sets deadline for recall of killer drug

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 (SFDA) instructed the drug's manufacturer, Anhui Huayuan Worldbest Biology Pharmacy Co, to retrieve all "Xinfu" drugs it produced in June and July before the deadline.

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 sterilization temperature and time below the state-required safety level.

After the first reports about problems with the injection came on July 27, the drug has been blamed for killing six and making at least 80 people sick. Severe adverse reactions include chest, kidney or stomach pains, vomiting and anaphylactic shock.

"Xinfu" produced before June could still be used, the administration said, but local departments should be vigilant about cases of adverse reactions.

Earlier investigation results showed the company 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 have been recalled, 173,000 are en route back to the factory, and 403,170 bottles have been located and sealed up in other areas.

The remaining bottles might 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.

Source: China Daily