Quality defect report to the one batch of KlavoPhar 875 mg/125 mg film-coated tablets (amocillin, clavulanic acid)
28.07.2014
PharmaS d.o.o., the marketing authorisation for KlavoPhar 875 mg/125 mg film-coated tablets (amoxicillin, clavulanic acid), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the quality defect of this medicine.
The quality defect report refers to the outer and inner labelling of the product where the "Expiry date” and "Batch No” of certain batches are labelled in English instead of the Croatian language on the blister and package. The following batches have been affected by this quality defect: KTABV0001, KTABV0002, KTABV0003, KTABV0004, KTABV0005, KTABV0006, KTABV0007, KTABV0008, KTABV0009.
The expiry date and the batch number are completely correct and correspond to those in the registration dossier.
The marketing authorisation holder will in agreement with HALMED, will advise all the distributing wholesalers to provide the information about this quality defect to their customers in order to avoid uncertainties in the use of this medicine.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. 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 with their doctor or pharmacist about the continuation of their therapy.
