Notice on the recall of three batches of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)


The Agency for Medicinal Products and Medical devices (HALMED) would like to inform on the recall of the batches B514AD and BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion of the marketing authorisation holder Medicuspharma d.o.o. from the Croatian market due to a suspected quality defect.

Following to suspected quality defects reported by healthcare professionals, HALMED and marketing authorisation holder have completed an investigation where this suspected quality defect may not be excluded. In addition, HALMED has received the statement on non-compliance with good manufacturing practice for active substances used for manufacturing this medicinal product of the company Zhuhai United Laboratories Co.

The recall is being conducted to the hospital pharmacy level, or delivery site to patients.

HALMED informed previously on its webpages on the stopping of delivery and use of the batches B514AD (on 27th October 2014) and BL10AD of this medicine (on 2nd March 2015).

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, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.