Other Information - Quality Defects and Recalls | Distribution, Manufacturing and Inspection .: HALMED

Notice on potential risk of cracks in vials of Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

27.10.2014

GlaxoSmithKline, the marketing authorisation 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) on the potential incident of cracks of these medicine.

More information is accessible under the link below.

Dear Healthcare Professional Letter on the potential risk for patients and healthcare personnel when handling broken/cracked Velcade vials

31.07.2014

Johnson&Johnson S.E. d.o.o. has in collaboration with the Agency for Medicinal Products and Medical devices (HALMED) sent a letter to healthcare professionals on the potential risk for patientrs and healthcare personnel on the potential risk for patients and healthcare personnel handling with broken/cracked Velcade 1 mg and 3,5 mg vials during use of the product.
Detailed information and the Dear Healthcare Professional Letter is accessible under the link below.

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.
Detailed information is accessible under the link below.

Information about printing error in the package leaflet of certain batches of Xeloda

16.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a quality defect report for Xeloda (capecitabine). This is due to a printing error in the package leaflet of certain batches of Xeloda.
In the paragraph 1 of the package leaflet “What is Xeloda and what is it used for”, there is an incorrect statement that the medicine contains 150 mf of capecitabine instead of 500 mg capecitabine. The affected batches containing the correct amount of 500 mg of capecitabine per tablet, which ia clearly stated in other parts of the package leaflet and labelling. The following batches have been affected by this quality defect , which means a printing error: B3010B02, B3024B03, X3197B05, X3164B02, X3111B02, X3048B02 and B3038B04.
Detailed information is accessible under the link below.