A medicine known as «fluimukan junior» 20 mg/ml intended for children is being urgently recalled from the Serbian market. This medicine is not registered in Serbia under this name, but is available under another brand name — «ACC kids» 20mg/ml 100 ml.
The company «Sandoz» d.o.o., alongside the Croatian Agency for Medicinal Products and Medical Devices (Halmed), announced last week that a batch of «fluimukan junior» 20 mg/ml oral solution is being recalled due to concerns of contamination by particles from the packaging.
Though the same medicine is present under the name «ACC kids» 20mg/ml 100 ml, it has not been confirmed to contain these particles. However, out of caution, the company has preemptively withdrawn the batch from the market.
Representatives from the company stated that patient safety is their priority in everything they do, and they are working closely with the appropriate authorities to ensure their medicines meet regulatory requirements and the highest quality standards.
On the German market, a product was recently detected in which particles from the contact packaging, specifically the inner side of the bottle cap, were found. This packaging is made from FDA and EU approved materials, thus the particles are considered harmless. In the products distributed in Serbia, these particles have not been confirmed.
