Kobayashi Pharmaceutical, based in Japan, is facing a deepening scandal over contaminated red yeast rice health supplements, branded as Benji-koji Choleste Help. By the end of last week, the situation had escalated to include 5 patient deaths and 100 hospitalizations linked to the consumption of the cholesterol-lowering supplement, with hundreds more seeking medical advice. On Sunday, Japan’s health ministry conducted a second on-site inspection at a Kobayashi plant in Wakayama prefecture.
The crisis was prompted by a statement from Kobayashi on Friday, indicating that blue mold had contaminated batches manufactured at the company’s Osaka site, resulting in the production of puberulic acid within the product. Japan’s Ministry of Health, Labor and Welfare (MHLW) confirmed the presence of puberulic acid in product samples. However, executives admitted that the exact cause of the health issues related to the product remains unknown. Kobayashi’s Osaka factory has been shut down amidst criticism for taking two months to address reports of health issues associated with Benji-koji Choleste Help, a product on the market since 2021.
The issue with Benji-koji emerged last week when Kobayashi also announced a product recall in the China market. Red yeast rice, a fermented species of mold (Monascus purpureus), contains high levels of Moncaolin K, a compound that lowers cholesterol and is used in many statin drugs. Kobayashi manufactures only 20% of its own raw material for the products, sourcing the rest from third-party suppliers in Japan and Taiwan. In China, the product is primarily sold through e-commerce platforms including Tmall, Pinduoduo, and JD.com.- Flcube.com
