Archive for MHRA Updates
MAGEC X System, NuVasive Specialized Orthopedics (NSO): UK suspension lifted, (DSI/2024/002)
Source: MHRA / Gov.uk 12.3.24 The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system...
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP)
Sodiofolin 50 mg/ml, solution for injection/infusion (folinic acid 400mg/8ml vial), EL(24)A/08 Source: MHRA / Gov.uk 12.3.24 medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified...
Class 4 Medicines Defect Information: Orifarm UK Ltd, Concerta XL 18mg & 36 mg prolonged release tablets, EL (24)A/07
Source: MHRA/Gov.uk 26.2.24 Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta...
Class 2 Medicines Recall: Novartis Pharmaceuticals UK Limited, Adakveo 10 mg/ml concentrate for solution for infusion, EL(24)A/06
Source: MHRA / Gov.uk 21.2.24 Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered...
Class 3 Medicines Recall: Torrent Pharma (UK) Limited, Ramipril 1.25mg tablets, EL(24)A/05
Source: MHRA/ Gov.uk 14.2.24 Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high...
Class 3 Medicines Recall: Torrent Pharma (UK) Limited, Ramipril 1.25mg tablets, EL(24)A/05
Source: MHRA / Gov.uk 13.2.24 Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and...
Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease:
Update to previous MHRA guidance on use. Where indicated, PCD can be considered as a treatment option for both critical limb ischaemia (CLI) and intermittent claudication (IC) patients. (DSI/2024/001) Source:...
Class 4 Medicines Defect Information: Exeltis UK Limited, Gepretix 100mg Capsules, EL (24)A/04
Source: MHRA / Gov.uk 1.2.24 Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix...
Class 4 Medicines Defect Information: Cadila Pharmaceuticals (UK) Limited, Pantoprazole 40 mg Gastro-Resistant Tablets, EL (24)A/03
Source: MHRA/ Gov.uk Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40...
Class 4 Medicines Defect Information: USV UK Limited, Sugammadex 100 mg/ml solution for injection (2 ml vial), EL(24)A/02
Source: MHRA/ Gov.uk 18.1.24 USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain...
Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Ltd, Cozaar 100mg film-coated tablets, EL(24)A/01
Source: MHRA / Gov.uk 4.1.24 Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets....
Coroner advises NHS England to warn prescribers about interaction of tramadol and warfarin
Source: The Pharmaceutical Journal 14.12.23 The coroner’s report says NHS England’s response “must contain details of action taken or proposed to be taken, setting out the timetable for action” or...