European Medicines Agency initiates a recall of certain batches of the medicinal product NovoMix 30 FlexPen and Penfill
Due to a quality defect, certain batches of the medicinal product NovoMix 30 FlexPen and Penfill are being recalled from the market in the EU Member States where affected batches have been distributed. The affected batches are not on the Croatian market and therefore the recall does not concern the Croatian market. The affected batches have never been placed on the market in Croatia, because the product for the Croatian market is not released at the manufacturing site that released the affected batches that are being recalled in the EU. Also, the recalled batches have never been placed on the market via interventional or parallel entry/import. The supply of the Croatian market with this medicine is going smoothly and there are other batches on the market not affected with this quality defect and therefore no reason for concern.
Detailed information for doctors and patients who purchased the medicine out of the Croatian territory is uccessble under the following link.