Drug Maker ordered to suspend plant operations over medicine mixing error
Drug manufacturer Taiyo Yakuhin Co. has been ordered to suspend operations at a plant after distributing a drug prepared using an incorrect amount of ingredients, it has been learned.
The Gifu Prefectural Government has ordered the Nagoya-based drug maker to suspend its business operations at the company's Takayama plant in Takayama, Gifu Prefecture, in accordance with the Pharmaceutical Affairs Law, after the factory failed to comply with the pharmaceutical formulation criteria during the production of its Gasport acid-reducing tablets for gastric ulcer treatment.According to the company, the irregularity was found in some 28,500 packages containing 100 tablets each, which were manufactured at the factory in February 2009 and shipped out between April and September the same year. Part of these tablets contained an excessive or insufficient quantity of famotidine, a major ingredient in the medicine that suppresses acid.
The production failed to conform to the pharmaceutical formula approved by the Ministry of Health, Labor and Welfare, in which the drug manufacturer specified the amount of famotidine contained in each Gasport tablet should equal 20 milligrams, with an estimated measuring error of up to 5 percent. However, it turned out that the tablets in the 28,500 boxes contained an error of up to 20 percent of the ingredient. The mistake was not detected during initial quality inspections, the company said.
The drug maker started to recall the drugs after the problem surfaced during in-house inspections in September last year. It retrieved the defective drugs from 3,116 medical institutions nationwide between late September and October the same year, and reported the problem to the Health Ministry. However, most of the drugs on the market had already been prescribed, and the company only managed to recall about 16.1 percent of all the medicine shipped.
"Those who were responsible for the quality inspection failed to report the problem properly to the management for fear of exposing the mixing error. We will do our best to prevent the same problem from ever happening again," said the company's public relations official.
The company will suspend operations at the Takayama plant from late this month for about 10 days. No health damage due to the drug has been reported so far.
No comments:
Post a Comment