List of Field Safety Notices from 16 to 20 June 2025.
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Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator, Becton Dickinson UK Ltd, EL(25)A/36
Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This is linked to the Class 2 Medicines Notification EL(25)A/22. This defect could increase the risk of the applicator device being contaminated with pathogens.
Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37
Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
RegulatoryConnect
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices
Updated MHRA guidance will help health institutions, such as NHS Trusts and Boards, safely design and make general medical devices for patients.