The number of products that used red yeast rice produced by Japanese drugmaker Kobayashi Pharmaceutical Co, which is being investigated for a suspected link to kidney disease and being preemptively recalled, has increased to 226 in Taiwan.
The Food and Drug Administration (FDA) on Monday last week issued an emergency recall of red yeast rice supplements from Kobayashi, citing the Osaka-based drugmaker on March 22 saying that its nutritional supplements containing red yeast rice might cause kidney problems, as it had received many reports indicating this was the case.
There were no import records of the five types of supplements that Kobayashi issued a recall on, but two Taiwanese importers of red yeast rice products made by Kobayashi had imported 56 batches between Jan. 1, 2022 and March 22, the FDA said.
Photo: EPA-EFE/JIJI PRESS
The two companies are pre-emptively recalling their products containing the red yeast rice ingredient, the agency said, adding that it has suspended applications for import inspection on Kobayashi’s red yeast rice ingredients and products.
The FDA also urged all food businesses that have used Kobayashi’s red yeast rice ingredients and products to stop using or selling them, and remove them from shelves.
They should report to the health authority, as required under the Act Governing Food Safety and Sanitation (食品安全衛生管理法), or face a fine of between NT$30,000 and NT$3 million (US$938 and US$93,780).
In Japan, Kyodo News reported that the drugmaker on Friday said that it has confirmed a fifth death possibly linked to its red yeast rice dietary supplements, and that it detected puberulic acid, a natural compound made from blue mold, in ingredients, and that the substance might have caused health problems for more than 100 people who reported falling ill after taking the supplements.
Meanwhile, FDA Deputy Director-General Lin Chin-fu (林金富) on Saturday confirmed that the agency received three reports of “unexpected reactions to food” associated with Kobayashi’s red yeast rice ingredient.
The FDA said yesterday afternoon that the number had increased to six as of 1pm yesterday.
The people reported feeling ill, but whether they have symptoms or a disease related to the supplements still needs further investigation, the agency said, adding that it would gather data for the consultative committee to assess the associations between the supplements and the unexpected reactions.
As of yesterday, the FDA’s data showed that the number of products in Taiwan that used Kobayashi’s red yeast rice ingredient and are being pre-emptively recalled has increased to 226.
A list of the products being recalled is available on the FDA’s Web site at: www.fda.gov.tw/tc/siteContent.aspx?sid=12919.
The FDA said consumers who have purchased products that used Kobayashi’s red yeast rice ingredient and have questions about it could call the FDA’s food safety hotline at 1919 or the consumers protection hotline at 1950.
People who felt ill after taking supplements that used Kobayashi’s red yeast rice ingredient could report their case to the FDA’s “unexpected reactions to health foods, nutrient foods, and capsules or tablet foods reporting platform” (http://qms.fda.gov.tw/tcbw/index.jsp) or call (02) 2321-0594, it said.
Additional reporting by CNA
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