MFDS Suspends Use of Topical Anesthetic Prescription Drug 'Incaine Gel'... Product Recall Initiated

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety announced on the 25th that it has suspended the use of the prescription topical anesthetic "Incaine Gel," manufactured and sold by "Person," after ethylene chlorohydrin (2-CE) was detected during product inspection, and requested hospitals and clinics to restrict its prescription.

Incaine Gel is a pharmaceutical product used to prevent damage in the rectum and colon caused by catheter insertion, male and female urethral surgeries, and various endoscopic examinations.

The 2-CE detected in Incaine Gel is mainly an intermediate of EO (ethylene oxide) residue that remains when EO gas is used in sterilization processes, and it is a substance that can also exist in the environment. Although it is currently difficult to determine the risk of the detected 2-CE, the Ministry of Food and Drug Safety explained that it decided on a preemptive measure for the safety of the public.

The Ministry instructed the manufacturer to promptly identify the cause. It also ordered a temporary suspension of Incaine Gel sales until management measures, including recurrence prevention, are established. The manufacturer is currently halting shipments of Incaine Gel and recalling distributed products.

Additionally, the Ministry of Food and Drug Safety, together with the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, requested medical professionals such as doctors and pharmacists to restrict prescriptions of the product and switch to alternative medicines.

This content was produced with the assistance of AI translation services.