The recall of three batches of the medicinal product Glibenclamid Genericon 3,5 mg tablets
20.11.2012
Genericon Pharma, d.o.o., the marketing authorisation holder for the medicinal product Glibenclamid Genericon 3,5 mg tablets, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about its decision to recall three batches (10A014, 10A16A and 10A16 B) of the medicinal product Glibenclamid Genericon 3,5 mg tablets, blister pack of 120 tablets, from the Croatian market.
The decision about the recall was taken after the analysis discovering a slight increase of the acidic acid content, alkyl esters of fatty acids and olefins. Even though toxic components have not been determined, it was decided to recall all the three batches affected by the aforementioned quality defect. The marketing authorisation holder has informed all Croatian distributers about the recall.
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.
