Notice on returning of the batch of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion to the Croatian market
13.03.2015
Following to the Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, published on 14 November 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs on the returning of the batch 15HG229F1 of this medicinal product. The procedure of discontinuation of the supply chain and use of this medicine was initiated as a precautionary measure, due to a suspected quality defect following to an allergic adverse reaction reported to HALMED.
Based on the conducted investigation and special quality control, HALMED concludes that the samples of the medicine comply to the specification with regard tested parameters. Following to these results, the temporary discontinuation of the supply chain and use of the batch 15HG2291 of this medicine is being alleviated and the existing stocks may be returned to distribution and use.
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.
