Information on temporary recall of Cefexin 100 mg/5 ml powder for oral suspension (cefiximum)
30.04.2014
Pliva Croatia d.o.o. has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the temporary recall of Cefiksim Jadran 100 mg/5 ml powder for orals suspension (cefiximum). The medicinal product is being temporarily recalled due to unclear graduation of the accompanying syringe graduated in kilograms of body mass instead of being graduated in millilitres of prepared solution, which might lead to a medication error when administering the medicine. The risk relates primarily to underdosing regarding application of only a half of the foreseen dose in cases when the medicine should be administered once a day. This incorrect dosing represents an insufficient therapeutic efficacy for patients.
The recall is being carried out at the pharmacy level. Only small quantities of this medicine have been so far placed on the Croatian market. The medicine will be available again on the market after the dosing syringe has been replaced.
There is a sufficient quantity of the alternate medicinal product with the same active substance and pharmaceutical form on the Croatian market and there will be no shortage.
So far, HALMED has not received any adverse reaction to Cefiksim Jadran 100 mg/5 ml powder for oral suspension related to incorrect dosing of the 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.
