Notice on quality defect of batches 1280064, 1281064, 1282064, 1283064 of Soludeks 40, 100 mg/ml solution for infusion
27.01.2015
The Croatian Institute for Transfusion Medicine, the marketing authorisation holder for Soludeks 40, 100 mg/ml solution for infusion has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of batches 1280064, 1281064, 1282064, 1283064 of this medicine.
It is discovered that the data on the inner packaging side are incorrectly printed in a way that on the site where the information on the expiry date should have been printed, data on the batch number are printed instead, wheras on the site intended for the batch number, the expiry date was printed instead. Data printed on the outer packaging are correct.
Concerned batches will be placed on the market with a notice for healthcare professionals.
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.
