Archive for MHRA Updates
Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets
Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery), EL (24)A/12 Source: MHRA / Gov.uk 10.4.24 Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg...
Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited,
Source: MHRA/Gov.uk 4.4.24 Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab), EL(24)A/11 Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that...
Counterfeits and unbranded copies of LifeVac anti-choking devices
Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used, DSI/2024/003 Source: MHRA / Gov.uk 25.3.24 Anti-choking devices are intended to...
Class 4 Medicines Notification: Fresenius Kabi Limited,
Sodium Chloride Intravenous Infusion 0.9% Freeflex, EL (24)A/10 Source: MHRA / Gov.uk 21.3.24 Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into the...
Class 3 Medicines Recall: Besins Healthcare (UK) Ltd
Source: MHRA / Gov.uk 19.3.24 Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol), EL (24)A/09. Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two...
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:...
