Notice on the temporary discontinuation of distribution and use of the batch B514ADof Medoclav 1000 mg + 200mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)
Medicuspharma d.o.o., the marketing authorisation holder for Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has initiated a procedure of temporary discontinuation of distribution and use of the batch B514AD of this medicine from the Croatian market.
The discontinuation procedure of distribution and use of this batch is carried out based on the quality defect reported from a healthcare professional about a different colour in two bottles from the same package.
HALMED has requested sampling of this batch from the Ministry of Health and samples will be forwarded to HALMED for the extraordinary quality control. The discontinuation of distribution and use of this medicine will be in effect until the quality control results have been completed and investigation results of the quality defect concluded, which will be promptly made publically available.
The temporary discontinuation in dispensing and use concerns only the batch B514AD and other available batches may further be delivered and used. The marketing authorisation holder has notified HALMED about other batches on the market that are available for treatment, so that the supply of the Croatian market will not be at risk.
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.