Fukui – Authorities on Monday began an on-site inspection of a drugmaker based in Fukui Prefecture whose antifungal medication, found to be tainted with a sleep-inducing component, is suspected of causing the death of two people in November and earlier this month.
The search of Kobayashi Kako Co., conducted by the health ministry together with the Fukui prefectural government and the Pharmaceuticals and Medical Devices Agency, is aimed at determining whether the company’s manufacturing and management standards are in violation of the law.
Toru Tanaka, chief of the health ministry’s Compliance and Narcotics Division, told reporters the same day that in addition to three types of the oral antifungal drug itraconazole sold under the brand name Meek recalled by the company, there have been reports of drugs manufactured using a process not approved by the government.
“This as an extremely serious incident,” said Tanaka, indicating that the ministry is considering taking strict administrative action against the company, including imposing a business suspension order.
The search of the drugmaker’s facilities by the health ministry follows one previously conducted by Fukui Prefecture on Dec. 9.
During the inspection, which is expected to take a few days, authorities will check work logs at the factory where the mix-up occurred and question staff in charge to determine whether the pharmaceutical company has been violating the law.
According to Kobayashi Kako, the problem occurred as a result of a container mix-up during the combination of ingredients for the drugs, and insufficient quality inspection prior to shipment.
There have been 155 cases of adverse health effects linked to the drug, including impaired consciousness, with 34 people having been hospitalized as of Sunday, according to the company. A woman in her 70s and a man in his 80s died after taking the tainted drug, though links between their deaths and the drug have yet to be confirmed.
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