Kwangdong Pharmaceutical's 'Benitol Tablets' Exceed Impurity Limits... 'Voluntary Recall Underway'

Kwangdong Pharmaceutical 'Benitol Tablets'

[Asia Economy Reporter Lee Chun-hee] An investigation revealed that Kadong Pharmaceutical's vascular strengthening agent 'Benitol Tablets,' used for hemorrhoids and other conditions, contained impurities exceeding the allowable limit. Kadong Pharmaceutical stated that it is voluntarily recalling the related products and that all currently distributed products are safe.

The Ministry of Food and Drug Safety announced on the 11th that nitrosamine impurity 'Nitrosomorpholine (NMOR)' was detected in Benitol Tablets (active ingredient 'Flavonoid fraction') above the daily intake limit (127ng/day). However, it added that the risk to human health is very low.

This safety investigation was prompted by overseas safety information from the European Medicines Agency (EMA), which reported that NMOR was detected above the daily intake limit in the drug. NMOR is one of the nitrosamine impurities in pharmaceuticals and is known to be unintentionally formed by the reaction of 'morpholine,' a substance used as a main ingredient, and residual 'nitrite' in excipients.

However, the Ministry of Food and Drug Safety confirmed that the possibility of additional cancer occurrence over a lifetime from taking the drug with NMOR exceeding the daily intake limit is at a 'negligible level,' estimated at '0.382 cases per 100,000 people,' indicating a very low risk to human health. This impact assessment assumes maximum intake from the product's approval date in July 1994 until the end of this year.

In this regard, the Ministry of Food and Drug Safety stated that Kadong Pharmaceutical is voluntarily recalling Benitol Tablets. Kadong Pharmaceutical explained, "Products from 2019 to 2020 are being recalled as a preventive measure, and last year's products are being partially recalled voluntarily," adding, "We are actively cooperating with health authorities and conducting all procedures with the consumer's health and safety as the top priority." Currently, only products confirmed to have NMOR levels below the daily intake limit have been shipped domestically since the 17th of last month.

Patients currently taking the drug should not stop taking it arbitrarily but should consult with a doctor or pharmacist to decide whether to continue. If necessary, products with other manufacturing numbers confirmed to have NMOR below the daily intake limit can be exchanged.

This content was produced with the assistance of AI translation services.