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Alerts, recalls and safety information: medicines and medical devices
Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation... In rare instances, the Allurion Gastric Balloon has not transited through the stomach or bowel as intended, leading to complications such as gastric outlet obstruction, small bowel obstruction and gastric perforation.
Alerts, recalls and safety information: medicines and medical devices
Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 2.5 mg Capsules, EL(26)A/25 Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.
Alerts, recalls and safety information: medicines and medical devices
Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27 Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcu…
Alerts, recalls and safety information: medicines and medical devices
Class 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension... Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.
Alerts, recalls and safety information: medicines and medical devices
Risk of severe harm from use of incorrect giving (administration) set for blood transfusion (DSI/2026/003) There is a potential for serious harm to patients if an intravenous (IV) infusion giving set is used instead of a blood transfusion giving set to deliver a transfusion of blood or blood components.
Alerts, recalls and safety information: medicines and medical devices
Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28 Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.
Alerts, recalls and safety information: medicines and medical devices
Class 3 Medicines Recall: Flamingo Pharma UK Ltd, Flucloxacillin Capsules BP 500mg, EL(26)A/32 Flamingo Pharma UK Ltd have informed the MHRA that certain packs of Flucloxacillin Capsules BP 500mg contain the incorrect PIL. The affected packs contain the PIL for Amoxicillin 500mg Capsules instead of the PIL for Fluclox…

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