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Alerts, recalls and safety information: medicines and medical devices
Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System (DSI/2025/004) The MHRA provides an update to previous guidance on the management of patients treated with the recalled Endologix Nellix EVAS System to reflect revised recommendations. All implanted patients in the UK with this device shou…
Alerts, recalls and safety information: medicines and medical devices
Class 2 Medicines Recall: Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension , CD Pharma Ltd, EL(25)A/35 CD Pharma Ltd have notified the MHRA of an error on the outer carton of the product for the batches listed in this notification. While the total active content statement is correct, the delivered dose content statement is in…
Alerts, recalls and safety information: medicines and medical devices
Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as... The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic…
Alerts, recalls and safety information: medicines and medical devices
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MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
Alerts, recalls and safety information: medicines and medical devices
Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34 Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contaminati…
Alerts, recalls and safety information: medicines and medical devices
Field Safety Notices: 21 to 25 July 2025 List of Field Safety Notices from 21 to 25 July 2025.
Alerts, recalls and safety information: medicines and medical devices
Class 4 Medicines Defect Notification: Erythromycin Stearate BP 250mg Tablets, Amdipharm UK Ltd, EL(25)A/32 Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.

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