Medytox botches Botox labeling but cites wrinkle in law

The Ministry of Food and Drug Safety ordered Medytox to recall and destroy 50-unit, 100-unit, 150-unit and 200-unit dosages of Meditoxin, Medytox’s bestselling botulinum toxin, citing violations of the Pharmaceutical Affairs Act.

The decision is the ministry’s second shot at Meditoxin since April.

“The Ministry has confirmed that Medytox did not receive the necessary requirement for lot release and violated labeling rules by not printing information in Korean,” it said in a Monday statement.

Best known as Botox, an Allergan brand name, botulinum toxin is used to reduce wrinkles by paralyzing muscles. Domestically introduced in 2006, Meditoxin was the first approved botulinum toxin in Korea and is sold in 60 countries.

Korean law obligates biologic pharmaceuticals to receive government approval per released batch. Botulinum toxin products must follow these procedures, but Medytox made sales to China without fulfilling these duties, the ministry said.

As penalty, the four Meditoxin dosages will lose their product licenses. The Ministry of Food and Drug Safety also sent messages to hospitals and clinics requesting a halt to the use of Meditoxin products.

Medytox fired back Tuesday morning, saying the ministry’s ruling is the result of a misunderstanding. The Meditoxin products in question were made for export purposes, which is why they did not have Korean language on their packaging and are exempt from lot-release review.

“Our products that served as the grounds for the Ministry of Food and Drug Safety’s permit cancellation were manufactured for export but were mistakenly seen as being for domestic release,” Medytox said in a Tuesday statement.

“The ministry’s application of the Pharmaceutical Affairs Act on an export-only medical product is clearly illegal,” said Medytox. “We plan to file a suit to challenge this administrative decision and halt its execution.”

An official from the Food and Drug Safety Ministry said Medytox’s claim is flawed.

“Medytox sold batches of Meditoxin products in Korea to third-party exporters, as opposed to hiring an agent that would take care of export administrative work in exchange commission fees,” said the official. “Even if the products eventually landed overseas, the former is viewed as sales having taken place in Korea, and therefore the products in question should have abided by domestic law.”

This is the ministry’s second attempt this year to withdraw the sale license for Meditoxin products. In April, it canceled permits for 50-unit, 100-unit and 150-unit dosages of the product for the use of an unapproved ingredient in the manufacturing process and fabricating safety test results between 2012 and 2015.

Its execution was blocked by the Supreme Court earlier this month in favor of Medytox. This extended the period for the Korean company to manufacture and sell Meditoxin products until the next court ruling.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]