Distribution, Manufacturing and Inspection

Notice on potential risk of cracks in vials of Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)


GlaxoSmithKline, the marketing authorisation for Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the potential incident of cracks of these medicine.

The investigation on the GSK manufacturing site in Worthing, UK, discovered cracks in a very low number of vials of these medicine. Taking account that there is a very low incidence of cracks and that the medicine is used by healthcare professionals that may discover eventual cracks in vials before use, the product will remain on the Croatian market. At the moment of delivery of every batch, healthcare professionals will be provided with information on the incidence of cracks in vials with instructions for handling and administration. Instructions for healthcare professionals are related visual inspection of vials, or inspection of glass integrity and inspection of appearance of the reconstituted solution that must be colourless or slightly yellowish.

The marketing authorisation holder has informed wholesalers on the potential incidence of cracks in Augmentin vials.

The replacement of the glass type is in process and will be implemented with the first next produced batch of these medicine for the Croatian market.

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.