[Alpha Biz= Kim Jisun] It has been confirmed that Aekyung Industrial failed to submit a legally required recall plan to South Korea’s Ministry of Food and Drug Safety (MFDS) within the designated deadline, despite being aware that a banned substance had been detected in some of its “2080” toothpaste products.

According to industry sources, Aekyung Industrial began internal testing on six affected 2080 toothpaste products on the 15th of last month. Nine days after the start of testing, on the 24th, the company reported to the Daejeon Regional Office of the MFDS that triclosan, a substance prohibited for use, had been detected in the products manufactured by China-based Domy Co.

Under the Pharmaceutical Affairs Act and the “Regulations on the Safety of Drugs and Related Products,” companies are required to submit a recall plan to the relevant regional MFDS office within five days of recognizing any safety or efficacy issues related to drugs or quasi-drugs.

However, Aekyung Industrial is believed to have made only an oral report at the time and did not submit a formal recall plan. Records show that the company eventually submitted the recall plan on the 5th of this month, more than 20 days after the inspection began on the 15th of last month.

This means the company violated regulations requiring a recall plan to be filed within five days of identifying a problematic ingredient.

 

 

[ⓒ 알파경제. 무단전재-재배포 금지]