Dear Pharmacist letter with instructions for dispensing one batch of the medicinal product Betazon 0,5 mg/g ointment
04.10.2012
The company "Jadran” - Galenski laboratorij d.d. (JGL), which is the marketing authorisation holder for Betazon 0,5 mg/g ointment, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to pharmacists with instructions for dispensing the batch 2162 of the aforementioned medicine due to the discovered print defect on the outer packaging of the single pack unit.
On the lateral cap of the outer packaging of the aforementioned batch, there is a print "Betazon cream” instead of "Betazon ointment”. Therefore, the company has decided to temporarily suspend the sale in pharmacies and inform HALMED. The Agency concluded that the discovered defect on the outer packaging did not represent a risk for patients, provided that pharmacists warned patients about it. Therefore, the sale of the product has been restaured.
The text of the Dear Pharmacist letter you may view here.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. 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 with their doctor or pharmacist about the continuation of their therapy.
