Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
Patients implanted with affected devices should expect to be contacted directly for a follow-up assessment, if required.
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components.
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
List of Field Safety Notices from 25 to 29 August 2025.
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
