Information on the recall of three batches of the medicinal product Natrii chloride infundibile, 100 ml solution for infusion


The Agency for Medicinal Products and Medical Devices (HALMED) has received from the Croatian Institute for Transfusin Medicine, the manufacturer and marketing authorisation holder for the medicinal product Natrii chloride infundibile, solution for infusion of 100 ml, information about the recall of three batches of the aforementioned medicinal product. The recall from the Croatian market of the batches 2301081, 2302081 and 2303081 is carried out due to the quality defect discovered during the product stability testing. Test results demonstrate a slight increase in pH value, as well as an increase in chloride content.

HALMED has not received any report of suspected quality defect or adverse reaction to aforementioned medicinal product.

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.