Controversy in manufacturing differently from permission matters
On-site investigations, etc. are also planned to proceed quickly
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The Ministry of Food and Drug Safety created a controversial drug that manufactured drugs differently from the license requirements. Binex (053030)The drug has been temporarily suspended from manufacturing and selling.
The Ministry of Food and Drug Safety announced on the 8th that it will determine provisional manufacturing and sales suspension and collection measures for Binex’s six medicines and initiate an investigation into the relevant production facilities in Busan.
The medicines in question are diabetes treatment’Amorin tablet’ (Glimepiride), depression treatment’Selectin capsule’,’Selectin capsule 10 mg’ (fluoxetine hydrochloride), arthritis treatment’Daxfen tablet’ (dexibuprofen), inflammation treatment ‘ Ropesin Tablet 250mg’ (ciprofloxacin hydrochloride hydrate), hypertension treatment’Cadil Tablet 1mg’ (doxazosinmesylate). An official at Binex said, “It is a matter of voluntarily reporting to the Food and Drug Administration last week, and it is true that there was a mistake.”
The Ministry of Food and Drug Safety plans to promptly carry out on-site investigations and necessary measures for Binex. The Ministry of Food and Drug Safety took the appropriate action as Binex submitted a recovery plan for the item manufactured differently from the licensed or reported items to the Busan Regional Food and Drug Administration. In addition, the product was converted to other alternative medicines, and cooperation was requested from doctors and pharmacists to ensure proper product recall. Also, through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, it requested the hospital to restrict prescription of the product.
An official of Binex said, “In the case of diabetes treatment, the dose to be put in one step has been known as if the total dose was adjusted.”
/ Reporter Kim Seong-tae [email protected], Reporter Seo Ji-hye [email protected]
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