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Regulator to do quality test on botulinum toxin products

Jeong Sae-im  Published 2019.10.31  14:24  Updated 2019.10.31 14:24

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The Ministry of Food and Drug Safety said it would conduct a quality evaluation on all botulinum toxin (BTX) products, as Medytox was recently found to have exported unqualified Meditoxin goods.

The ministry made public its plan while replying to the written inquiry during the National Assembly Health and Welfare Committee’s audit of the ministry.

The committee member lawmakers Kim Soon-rye (Liberty Korea Party), Yun So-ha (Justice Party), and Yoon Il-gyu (Democratic Party of Korea) asked the ministry’s response to the export of unqualified Meditoxin products and how it would handle the situation.

“According to our ministry’s order to recall and discard the products, Medytox is recollecting them. The company is expected to complete the recall by Nov. 17,” the food and drug safety ministry said. “We are checking the quality of other Meditoxin products currently in circulation in the market.”

The ministry added that it would check the status of manufacturing and quality control of all BTX makers and conduct a quality evaluation of the entire products.

On Aug. 26, an informer filed a complaint with the ministry about the poor quality of Meditoxin products made in a specific period. The ministry inspected five batches of Meditoxin stored for sale. It found that three batches for export failed to meet the standards, while the rest two for domestic sales were qualified. On Oct. 16, the ministry ordered the company to recall and discard unqualified products whose valid dates were not over.

The regulator also said it would enhance quality control after granting drug licenses.

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