Distribution, Manufacturing and Inspection

Notice on recall of one batch of Oronazol 20 mg/g shampoo


Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for Oronazol 20 mg/g shampoo has notified the Agency for Medicinal Products and Medical Devices (HALMED) of the recall of the batch EKB1Z00, EUR code: 6160803 from wholesalers and pharmacies. The recall is being conducted due to a batch labelled in Slovenian and mistakenly placed on the Croatian market during distribution.

This recall of the medicine labelled for the Slovenian market will not affect the regular supply chain with this medicine in Croatia.

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, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.