Another facility inspected amid fears about the fitness of Japan’s Kobayashi Pharma

TOKYO, March 31 (Xinhua) — Following suitability considerations on red yeast rice supplements, known as “beni-koji,” made through Japanese pharmaceutical company Kobayashi, Japan’s Ministry of Health and the local government conducted on-site inspections at the company’s facilities on Sunday. . factory in Wakayama Prefecture in western Japan.

The inspection, conducted under the Food Hygiene Act, was carried out jointly through the Ministry of Health, Labor and Welfare (MHLW) and the Wakayama Prefectural Government to investigate the root cause of the reported health problems.

As of Friday, the Osaka-based pharmaceutical company’s red yeast rice nutritional supplement has been linked to five deaths and more than 100 hospitalizations, and about 700 more people have sought medical advice or are in the process of seeking medical advice.

The death-related product called Beni-koji Choleste Help, a type of pill advertised to lower LDL cholesterol levels, is manufactured at Kobayashi Pharmaceutical’s plant in Osaka, which closed in December 2023.

The Wakayama plant in Kinokawa City, where equipment was transferred from the Osaka plant after its closure in December 2023, is engaged in the production of raw materials for supplements.

The inspection marks the second consecutive day of inspections conducted by MHLW following its arrival at the Osaka plant on Saturday.

According to MHLW and the company, an unintentional component called “pubererulic acid,” derived from blue mold, was detected in the company’s product.

The substance is a potent antibacterial and antimalarial agent that can be toxic, but it is not yet clear to what extent drinking it could pose health hazards or cause kidney damage, according to the ministry.

The company launched Choleste Help in February 2021 and sold around 1 million programs by the end of February this year.

The worsening health problems intensified complaints about Kobayashi Pharmaceutical’s slow response, as it took the company about two months to receive reports of health problems to announce the voluntary recalls.

Kobayashi Pharmaceutical’s voluntary recall of beni-koji products as a food item has now expanded nationwide, affecting products such as sake, candy, bread, and miso.

Previous reports had shown that the company had fermented rice with red yeast to 52 manufacturers.

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