Manufacturing detection, unlike permission and notification matters… Overall quality control check
The Ministry of Food and Drug Safety (Director Kang-rip Kim) announced on the 8th that it will determine the temporary manufacturing, sales suspension, and recall measures for six drugs of the pharmaceutical manufacturer Binex Co., Ltd., and initiate an investigation into the relevant factory (located in Busan).
The drug is △Amorine tablet (Glimepiride) △Selectin capsule (fluoxetine hydrochloride) △Daxfen tablet (dexibuprofen) △Lopsin tablet 250mg (ciprofloxacin hydrochloride hydrate) △Selectin capsule 10mg (fluoxetine hydrochloride) △Cadyl tablet 1mg (Doxazosin mesylate) and the like.
This measure was decided by the Ministry of Food and Drug Safety as a precautionary measure against Binex’s submission of a recovery plan for the item manufactured differently from the licensed or reported items to the Busan Regional Food and Drug Administration.
The Ministry of Food and Drug Safety conducted an investigation to confirm the overall manufacturing and quality control of the plant.
The Ministry of Food and Drug Safety has distributed a safety bulletin to doctors, pharmacists, and consumers, asking experts such as medicines and pharmacists to convert the product to other alternative medicines and cooperate so that product collection can be performed properly.
In addition, through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, it requested hospitals and clinics to restrict prescription for the product.
The Ministry of Food and Drug Safety plans to promptly carry out on-site investigations and necessary measures for Binex.
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