Binex, amid controversy over the manipulation of raw materials, received a temporary suspension of manufacturing, sales, and collection of six medicines from the Ministry of Food and Drug Safety. The Food and Drug Administration initiates an investigation into the manufacturing facility in question.
The Ministry of Food and Drug Safety announced on the 8th that it will determine provisional manufacturing, sales suspension, and recall measures for six medicines of the pharmaceutical manufacturer Binex, and initiate an investigation into the corresponding Binex factory in Busan.
The targets who received provisional suspension of manufacturing and sales and collection measures this time are ▲Amorine tablet (ingredient name glimepiride) ▲Selectin capsule (ingredient name fluoxetine hydrochloride) ▲Daxfen tablet (ingredient name dexibuprofen) ▲Lopsin tablet 250mg (ingredient name ciprofloxacin hydrochloride hydrate) ▲ There are a total of 6 items including 10 mg of selectin capsule (ingredient name fluoxetine hydrochloride) ▲ 1 mg of Cadillac tablet (ingredient name doxazosin mesylate).
The Ministry of Food and Drug Safety has distributed a safety bulletin requesting cooperation so that the product can be converted to another alternative medicine and product recall can be carried out appropriately to experts such as medical and pharmacists. In addition, through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, it requested hospitals and clinics to restrict prescriptions for the product.
Binex has submitted a recovery plan for items manufactured differently from the matters that have been approved or reported to the Busan Regional Food and Drug Administration.
In addition, the Ministry of Food and Drug Safety plans to conduct an investigation to confirm the overall manufacturing and quality control of the plant.
An official from the Ministry of Food and Drug Safety said, “We plan to promptly carry out on-site investigations and necessary measures for Binex.”