MFDS Adds 32 More Vinex-Manufactured Drug Products to Manufacturing and Sales Suspension, Totaling 38 Items

Published 09 Mar.2021 15:49(KST)

[Asia Economy Reporter Lee Chun-hee] Following the provisional suspension of manufacturing and sales and recall measures for six pharmaceutical products manufactured by the pharmaceutical company Binex, the Ministry of Food and Drug Safety (MFDS) has additionally imposed the same measures on 32 other products manufactured using the same method.

On the 9th, the MFDS announced that after conducting an on-site investigation of Binex, it found that the manufacturing process differed from the approved or reported details as of the 8th. Therefore, the MFDS decided to take the same measures for 32 products from other pharmaceutical companies manufactured using the same method as the previously suspended products.

On the 8th, following Binex's submission of a recall plan for products manufactured differently from the approved or reported details to the Busan Regional MFDS Office, measures were taken for six products: Amorin Tablets (Glimepiride), Selectin Capsules (Fluoxetine Hydrochloride), Daxpen Tablets (Dexibuprofen), Lofsin Tablets 250 mg (Ciprofloxacin Hydrochloride Hydrate), Selectin Capsules 10 mg (Fluoxetine Hydrochloride), and Cadil Tablets 1 mg (Doxazosin Mesylate).

After the MFDS announcement, Binex disclosed on the 8th that sales of these six products amounted to 2,615.67 million KRW in 2019 and 2,531.9 million KRW last year, representing 2.09% and 1.88% of total consolidated sales, respectively.

However, the MFDS's on-site investigation confirmed that there are other products manufactured in the same way besides the six products, leading to the same measures being applied to 32 additional products.

The 32 products are ▲Dekpen Tablets (Kyungbo Pharmaceutical) ▲Dicarol Tablets (Ildong Pharmaceutical) ▲Sonipen Tablets 300 mg (JW Shinyak) ▲Exipen Tablets (HanAll Biopharma) ▲Nuroxacin Tablets (Gujoo Pharmaceutical) ▲CiploxQ Tablets 250 mg (Joah Pharmaceutical) ▲Ciroxin Tablets 250 mg (Jinyang Pharmaceutical) ▲Ciroctan Tablets 250 mg (IQURE) ▲Cipron Tablets 250 mg (Hana Pharmaceutical) ▲Poonglim Ciprofloxacin Hydrochloride Hydrate Tablets (Poonglim Pharm) ▲Difmax Capsules 20 mg (Light Pharm Tech) ▲Slecetin Capsules (Dongkook Pharmaceutical) ▲Youngproctin Capsules (Youngpoong Pharmaceutical) ▲Oxetin Capsules (Joah Pharmaceutical) ▲Oxygreen Capsules (Mothers Pharmaceutical) ▲Wellfit Capsules (Wooridle Pharmaceutical) ▲Unijac Capsules 20 mg (Unimed Pharmaceutical) ▲Ponoxetine Capsules 20 mg (JW Shinyak) ▲Purusetin Capsules 20 mg (Mirae Pharmaceutical) ▲Ploxen Capsules (Hwail Pharmaceutical) ▲Pronine Capsules (CMG Pharmaceutical) ▲Slecetin Capsules 10 mg (Dongkook Pharmaceutical) ▲Youngproctin Capsules 10 mg (Youngpoong Pharmaceutical) ▲Obetin Capsules (Intro Biopharma) ▲Oxetin Capsules 10 mg (Joah Pharmaceutical) ▲Wellfit Capsules 10 mg (Wooridle Pharmaceutical) ▲Unijac Capsules 10 mg (Unimed Pharmaceutical) ▲Pronine Capsules 10 mg (CMG Pharmaceutical) ▲Ploxin Capsules 10 mg (New One Science) ▲Flumin Capsules 10 mg (Taeguk Pharmaceutical) ▲Grill Tablets (SPC) ▲Gluby Tablets (Alvogen Korea).

The MFDS expects that these products have a low production volume share and will not affect domestic supply and demand.

The MFDS has distributed safety alerts to medical professionals, pharmacists, and related organizations such as consumer agencies, requesting cooperation to switch to alternative medicines and ensure proper product recalls. Additionally, through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, the MFDS has requested hospitals and clinics to restrict prescriptions of these products.