A drugmaker was ordered Tuesday to suspend its business for 116 days, the longest such order ever imposed on a pharmaceutical company in the country, after systematically making up fictitious production records on nearly 80% of its 500 products.
The order for Kobayashi Kako Co. will be effective starting Wednesday through June 5, said the Fukui Prefectural Government, which authorizes the generic drugmaker in Awara to produce and sell medicine. The company was also found to have skipped pre-shipment quality tests for some products since the late 1970s and forged results, among other legal violations.
Kobayashi Kako came under scrutiny late last year after announcing it would recall anti-fungal medicine tainted with a sleep-inducing component, with adverse health effects reported in a dozen cases. The health ministry later conducted an on-site investigation of the company based in the central prefecture.
Authorities now believe the drugmaker's sloppy manufacturing controls resulted in the component being mixed into the oral antifungal medicine in June.
The number of consumers affected by the incident later increased. A total of 239 people, about 70% of those who took the drug, had adverse health effects, including impaired consciousness, while two people, in their 70s and 80s, died, according to the company.