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Japanese authorities on Wednesday ordered drugmaker Kobayashi Pharmaceutical to recall three dietary supplement products containing red yeast rice, or beni koji, after they were linked to two deaths.
The Kobayashi red yeast rice scandal (Japanese: 紅麹サプリ事件) is an ongoing widespread supplement contamination that was first noted on 22 March 2024, resulting in numerous health problems to people taking the supplements in Japan and Taiwan. Up to 80 people died after taking the supplements, with at least 500 more hospitalized.
Red yeast rice or red rice koji is a bright reddish purple fermented rice, which acquires its color from being cultivated with the mold Monascus purpureus.Red yeast rice is what is referred to as a kōji in Japanese, meaning "grain or bean overgrown with a mold culture", a food preparation tradition going back to ca. 300 BC.
The FDA letter stated, “Because Red Yeast Rice and Red Yeast Rice/Policosanol Complex contain red yeast rice with enhanced or added lovastatin and bear claims about lipid control and other cardiovascular benefits supplied by this ingredient, they cannot be marketed as dietary supplements.” [6] [7]
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M. purpureus has been used for over a thousand years in oriental fermented foods, including red kōji-kin, red yeast rice, or ank-kak, rice wine, kaoliang brandy, and as the coloring agent for Peking duck.
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