The Ministry of Food and Drug Safety ordered Medytox to recall and discard mandatorily some of the company’s Meditoxin (export name: Neuronox) products sold overseas due to poor quality.
|Medytox’ botulinum toxin Meditoxin (Credit: Medytox)
The ministry issued the order after some of the botulinum toxin (BTX) products failed the regulator’s quality test. Medytox has exported 3.3 billion won ($2.79 million) worth of defective items, the ministry said.
The government inspected the samples of three batches of Meditoxin stored for export at the company’s third plant in Osong, North Chungcheong Province, in late August.
The inspection results showed that the samples failed to meet the standards in titer testing, which is related to drug efficacy, and in moisture content testing. Accordingly, the ministry on Wednesday ordered the company to recall and dispose of the finished products made from the specimens.
The problematic anti-wrinkle injections have manufacturing numbers “TFAA1601,” “TFAA1602” and “TFAA1603.” The date of manufacture was October 5, 11, and 18 in 2016, respectively, and only one batch has not expired.
The ministry ordered the recall of TFAA1603 products, which have not expired. It also ordered the company to recollect TFAA1601 and TFAA1602 products if they were still in the market.
Medytox plans to recollect and discard the BTX products, after discussing it with a partner company.
Most of the products that tested inadequate seem to have been already used by foreign consumers, who might pursue litigation against Medytox.
“We sincerely apologize for any concerns that consumers may have about this measure. There have been no complaints received so far regarding these products. If we receive any of them in the future, however, we will take actions such as compensation for damages by legal procedures," Medytox said.
The authorities have yet to identify the exact number of the finished goods produced in the three batches. Also unknown are who used them and how, and to which country the products were shipped. Meditoxin is sold under the name Neuronox in 31 countries, including Japan, Thailand, Brazil and Iran.
The government initiated the inspection after a former Medytox employee reported to the regulator that the company found unqualified Meditoxin in safety tests at its plant in Osong but fabricated data.
If a drugmaker wants to receive approval for an additional manufacturing site, it should prove that the drug produced at a new plant has the same quality as the products manufactured in the existing factory.
According to the former Medytox worker’s testimony, revealed on Oct. 11 through local media, News 1, the stability tests for the three batches in the third month showed that the moisture content exceeded the standard level. The company made false data and gained the nod, however.
Later, the food and drug ministry inspected the three batches and found that the former employee’s allegation was highly likely true.
Medytox has repeatedly said it was difficult to trust the former worker’s words because the informer would have worked with Daewoong Pharmaceutical, which is in legal fights with Medytox over the origin of the BTX strains.
After the recall order, the company changed its stance, however, saying it would do its best to investigate the facts and prevent a similar mishap through continuous monitoring.
The food and drug safety ministry plans to expand the investigation into local BTX products. Even though it did not find any issue in the two batches of Meditoxin for domestic demand, it would collect samples of finished items in other batches for quality testing, the government said.