Distribution, Manufacturing and Inspection

Recall of two batches of Ibustar for children 20 mg/ml oral suspension (ibuprofen)


Berlin-Chemie Menarini Croatia d.o.o., the marketing authorisation holder for Ibustar for children 20 mg/ml oral suspension (ibuprofen), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batches 32004 and 41005 of this medicinal product due to a discovered quality defect.

The marketing authorisation holder Berlin_Chemie Menarini Croatia d.o.o. has started the recall of these batches from the Croatian market to the ppharmacy level as a precautious measure. The manufacturer is carrying out recalls also in other countries where the product has been distributed.

There are other medicinal products of the same pharmaceutical form and same active substance available on the Croatian market.

We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.