MFDS Initiates Administrative Procedures for 'Botulinum Toxin' Violating National Release Approval

by Byun Seonjin

Published 02 Jun.2023 08:46(KST)

Updated 02 Jun.2023 08:47(KST)

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The Ministry of Food and Drug Safety announced on the 2nd that it has detected that Huons Biopharma's botulinum toxin preparation, 'Liztox Injection 100 Units,' was sold domestically without receiving national batch release approval, and has initiated administrative actions including product license cancellation and recall and disposal procedures.

Liztox Injection. [Photo by Huons]

According to the Ministry, biological products requiring special attention for health and hygiene must undergo review of manufacturing and quality control data by the Ministry of Food and Drug Safety and obtain batch release approval before domestic sales.

Additionally, since the product was intended exclusively for export but was sold domestically, it constitutes a violation of the Pharmaceutical Affairs Act, and the manufacturing facility will face a six-month suspension of all manufacturing operations, the Ministry stated. Export-only pharmaceuticals are approved on the condition that they are manufactured solely for export based on specifications requested by importers and are not sold domestically.

The Ministry has issued recall and disposal orders to prevent the distribution of the violating product domestically, alongside initiating administrative disciplinary procedures. Considering the time required for administrative processes, a suspension of use has been implemented to protect consumers.

Furthermore, an urgent safety notice was distributed to professionals such as doctors and pharmacists, requesting cooperation to replace the product subject to license cancellation with other products and to ensure proper product recall. The Ministry also reported that it has requested the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to guide hospitals and clinics not to use the product.