Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion defect
Class 4 medicines defect notification: The MHRA has published a Class 4 medicines defect notification for Gemcitabine 2g/52.6ml concentrate for solution for infusion.
Published: 4 September 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a class 4 medicines defect notification for Gemcitabine 2g/52.6ml concentrate for solution for infusion. Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within a specific batch of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
Further information, advice and details of the affected batch can be found on the MHRA website.