Medicinal Products

Recall of three batches of the Betrion mast (mupirocin)


Company Pliva Hrvatska d.o.o., the marketing authorisation holder of the Betrion mast (mupirocin), has notified Agency for Medicinal Products and Medical Devices (HALMED) about the recall of batches no. 331104, 332104, 131084 of this medicinal product, due to suspected quality defect.

The suspicion in quality defect is based on potential penicillin contamination of active substance batch no. W656993 which has been used in production of mentioned batches. The recall is carried out to the level of wholesales and according to information available to HALMED, batches listed above are no longer available in wholesales.

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.