Investigation Launched at Busan Manufacturing Plant
[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 8th that it has decided to temporarily suspend the manufacturing and sales of six pharmaceutical products by the drug manufacturer Binex and initiate an investigation into the manufacturing facility located in Busan.
The products subject to suspension of manufacturing and sales are Amorine Tablets (Glimepiride), Selectin Capsules (Fluoxetine Hydrochloride), Daxpen Tablets (Dexibuprofen), Lofsin Tablets 250mg (Ciprofloxacin Hydrochloride Hydrate), Selectin Capsules 10mg (Fluoxetine Hydrochloride), and Cadil Tablets 1mg (Doxazosin Mesylate).
This measure was decided by the Ministry of Food and Drug Safety as a preventive action after Binex submitted a recall plan to the Busan Regional Food and Drug Administration for the items that were manufactured differently from the approved or reported specifications. The Ministry will conduct an investigation to verify the overall manufacturing and quality control at the manufacturing site.
The Ministry has distributed a safety alert requesting medical professionals such as doctors and pharmacists to switch to alternative medicines and to cooperate to ensure the proper recall of the products. Additionally, through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, it has requested restrictions on prescriptions of these products at hospitals and clinics.
A Ministry official stated, "We plan to promptly proceed with necessary measures along with an on-site investigation of Binex."
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