Withdrawal of a batch of the Augmentin injection 1.2 g packaging with 5 bottles/box
28.03.2009
The Agency for Medicinal Products and Medical Devices has withdrawn a batch of the Augmentin injection 1.2 g packaging with 5 bottles per box, batch no. 392761, of the marketing authorisation holder GlaxoSmithKline d.o.o., Zagreb, due to suspected quality defect. The medicine was manufactured by SmithKline Beecham Pharmaceuticals, UK, and its active substances are amoxicilin and clavulanic acid.
On 28 March 2009, the Agency received the information on possible quality defect for the mentioned batch of the medicine, reflected in a changed appearance of the powder for solution for injection or infusion, which is white, lumpy and sticking to the walls of the bottle.
The Agency notified all hospitals, health clinics and pharmacies of this withdrawal.
