Kobayashi Kako under inspection over contaminated medicines

pharmafile | December 22, 2020 | News story | Manufacturing and Production Kobayashi Kako, rilmazafone 

Japanese pharmaceutical firm Kobayashi Kako is under inspection by authorities after it emerged that the company adopted illegal manufacturing procedures for several of its products, including a contaminated skin treatment that led to two deaths.

The firm was inspected on suspicion of violating the Pharmaceuticals and Medical Devices Act, after an antifungal treatment that had been inadvertently tainted with the sleep-inducing drug Rilmazafone caused the deaths of two people in Japan.

Numerous reports of health damage were also made by others who took the oral skin treatment, “Itraconazole tablet 50 ‘MEEK’”, including 34 people who were admitted to hospital as a result of ingesting the contaminated drug.

It has since been reported by Mainichi Shimbun that Rilmazafone was added to the drug during the production process to make up for shortages, and that the company neglected to conduct checks despite the procedural violation being logged in work records.

Two other types of the same drug – “Itraconazole tablet 100 ‘MEEK” and “Itraconazole tablet 200 ‘MEEK’” – had also been produced in violation of state-authorised procedures, but were not found to contain the same contaminant.

Kobayashi Kako has been recalling the medications in question since early December, but it has also emerged that the company produced a number of other drugs under procedures that were not authorised by Japan’s health ministry.

According to reports, the Fukui Prefectural Government is considering issuing a business suspension order against the firm, on the grounds that it neglected safety inspections.

Toru Tanaka, head of the health ministry’s Compliance and Narcotics Division, who inspected the company’s offices, told Mainichi Shimbun: “It is extremely serious as the issue concerns the pharmaceutical industry as a whole. It has been revealed that the company adopted unauthorized procedures for drugs other than Itraconazole. It is inevitable for the firm to be slapped with a business suspension order.”

Darcy Jimenez

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