MFDS "Unimed Pharmaceutical's Quality-Noncompliant Eye Drop Injection Sales and Use Suspended"

[Asia Economy Reporter Cho Hyun-ui] Quality nonconformities were confirmed in two manufacturing batches of Unimed Pharmaceutical's ophthalmic injection 'UniAlju 15mg' (Sodium Hyaluronate), used as an adjunct therapy for cataract surgery, leading to a recall and suspension of sales and use.

The Ministry of Food and Drug Safety (MFDS) announced on the 11th that "manufacturing and shipment of the product will be temporarily suspended until the investigation and review are completed, and prescription restrictions have been requested at hospitals and clinics."

The MFDS is investigating Unimed Pharmaceutical regarding compliance with Good Manufacturing Practice (GMP) standards related to this quality nonconformity. Administrative actions will be taken if violations are found.

Additionally, to identify the cause, products predicted to be affected among those produced and distributed by the manufacturer will be collected and tested.

The MFDS has issued a safety alert requesting cooperation from medical professionals such as doctors and pharmacists to switch to alternative medicines and ensure proper product recall. Prescription restrictions for the product have also been requested at hospitals and clinics through the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service.

The MFDS urged, "If any adverse reactions or abnormal signs suspected to be related to the product occur, please report them to the Korea Institute of Drug Safety & Risk Management."

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