Notice on temporary discontinuation in the supply chain and use of the batch 718356 of Augmentin 1000 mg+200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)
11.06.2015
GlaxoSmithKline d.o.o., the marketing authorisation holder 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) of a temporary discontinuation in the supply chain and use of the batch 718356 of this medicinal product due to a suspected quality defect.
The suspicion in a quality defect is following to an inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at the GSK manufacturing site in Worthing, UK. This discontinuation of the supply chain and use will be in effect by the end of the GMP audit.
According to HALMED’s data, this batch is no longer available in wholesalers in the Republic of Croatia.
