Japan orders recall of supplements after two deaths

Japanese authorities yesterday ordered drugmaker Kobayashi Pharmaceutical to recall three dietary supplement products containing red yeast rice, or

“beni-koji,” after they were linked to two deaths and more than 100 hospitalizations, while in Taipei, the Food and Drug Administration (FDA) has recalled 121 products containing the yeast.

Two Taiwanese importers of red yeast rice products made by Kobayashi had issued recalls, FDA Director-General Wu Shoumei (吳秀梅) told a weekly news briefing.

New Taipei City-based SHS Biotech Co (三合興產業股份) recalled 405kg of its ingredients, while Taichung-based Healthtake Corp (和司特) recalled more than 3,000kg from its 39 downstream businesses, Wu said.

As of 9pm on Tuesday, 31 companies and suppliers voluntarily reported their products containing red yeast rice ingredients and removed them from shelves, she said.

In Japan, at least 106 people have been hospitalized, and many more are believed to have been sickened, after taking Kobayashi’s supplements, which were marketed as helping to lower cholesterol levels, the government said.

Medical studies describe red yeast rice as an alternative to statins for lowering high cholesterol, but also warn of a risk of organ damage depending on its chemical makeup.

“The total number of suspected deaths [is now] two,” while “106 cases of potentially linked hospitalization also came to light,” Japanese Chief Cabinet Secretary Yoshimasa Hayashi told reporters.

It is unclear if all the illnesses are directly linked to

beni-koji.

Beni-koji contains Monascus purpureus, a red mold that is also used as a red coloring in some foods.

Kobayashi this week urged 52 manufacturers to recall a wide range of products, and in addition to its products, more than 40 others from other companies containing beni-koji — including miso paste, crackers and a vinegar dressing — were recalled, starting last week, a Japanese Ministry of Health, Labour and Welfare official said.

The official warned that there could be more victims in the days ahead. He asked everyone to stop ingesting anything with

beni-koji in it.

Those with health problems, such as weak kidneys, could be especially vulnerable, he said.