The Food and Drug Administration (FDA) on Monday said it has issued an emergency recall of red yeast rice supplements from Japan’s Kobayashi Pharmaceuticals after reports of a suspected link to kidney disease.
The Osaka-based company last week issued a recall of products containing “beni-koji,” or red yeast rice, after some users reported kidney or other health issues, NHK reported on Friday last week.
Thirteen people reported adverse reactions, six of whom have been hospitalized while one underwent dialysis, the media outlet said.
Photo from the Kobayashi Pharmaceuticals Web site
Company officials said that an analysis identified contents that should not be in the product, although the cause of the health issues remains unknown, the report said.
The supplement is marketed as able to help lower cholesterol and blood pressure.
About 80 percent of the product is reportedly exported, including to Taiwan.
Speaking to reporters on Monday, FDA Deputy Director-General Lin Chin-fu (林金富) said that 56 batches have been imported by two local companies since Jan. 1, 2022.
The importers have already been instructed to recall the product, while further imports would be stopped at the border, Lin said.
The FDA is working with local governments to discover where the products are being sold, he said, adding that the companies’ names would not be publicized, as they have not convened any regulations and are cooperating with the recall.
However, both companies have posted notices on their own Web sites informing about the recall and advising buyers to avoid consuming the product.
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