Notice on temporary discontinuation in the supply chain and use of the batch BL10AD of Medioclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)
02.03.2015
Medicuspharma d.o.o., the marketing authorisation holder for Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has initiated a procedure of temporary discontinuation in the supply chain and use of the batch BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid).
The procedure of discontinuation in the supply chain and use of this batch is being conducted following to a reported quality defect by a healthcare professional. The quality defect relates to appearance of an unusual colour of the diluted product (dark yellow solution colour).
HALMED has requested sampling from the Ministry of Health to perform a special quality control of the samples. The discontinuation in the supply chain and use of this batch will be in effect until the results of the extraordinary quality control have been obtained and conclusions made, which will be made publically available
The temporary discontinuation of the supply chain and use concerns only the batch BL10AD of this medicine and all other remaining batches of the medicine may be further delivered and used.
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 via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
