The Ministry of Food and Drug Safety ordered Medytox on Oct. 17 to recall and discard some of its botulinum toxin products, Meditoxin, which were licensed for exports, as it judged that some of Meditoxin products were unfit for quality standards.
The ministry has been investigating Medytox, visiting the Osong plant on-site after receiving a tip from the Anti-Corruption and Civil Rights Commission that it had engaged in illegal activities in the production of Meditoxin. Medytoxin is the product that Medytox received approval from the ministry in March 2006 for the first botulinum toxin product in Korea.
The ministry said that after conducting quality tests on Medytox products, there was no defect in quality in domestic products, but the nonconformities in the potency and moisture content were found in products for export.
In addition, it said that some products, whose expiration date has been already passed, but still remain in the market, need to be recalled.
It has yet to be confirmed how much of these products are exported or distributed abroad, as some of the stored products have been inspected. In the future, Medytox must identify how much the product is distributed overseas and submit a recovery plan that specifies the quantity.
Medytox said, "We sincerely apologize to customers for their concerns about the ministry's recall order. Medytox will conduct a recall process in consultation with related companies while investigating whether or not there are any defects in the medicine."
