Glosarij d.o.o. Podgorica, as the Marketing Authorisation Holder for Urutal 8 mg tablets, blister pack containing 100 (5 × 20) tablets, manufactured by Belupo, lijekovi i kozmetika d.d., Croatia, in cooperation with the Institute for Medicines and Medical Devices, is recalling batch 20548066 of the medicinal product from the market.

The recall is being carried out as a precautionary measure at the wholesale and pharmacy level. During routine stability testing conducted by the manufacturer, an out-of-specification result was obtained for an impurity parameter.

Based on the currently available data, the identified deviation does not indicate a safety risk to patients using this medicinal product.

Patients currently using the medicinal product concerned are advised to consult their physician regarding the continuation of their treatment.