Archive for MHRA Updates
Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
Source: MHRA/Gov.uk 04.09.2025 Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does...
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
Source: MHRA/Gov.uk 04.09.2025 An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular...
Class 4 Medicines Defect Notification: Ipca Laboratories UK Limited, Various Products, EL(25)A/42
Source: MHRA/Gov.uk 26.8.2025 Ipca Laboratories UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required...
Class 4 Medicines Defect Notification: Fexofenadine Hydrochloride 120mg film-coated tablets, Chanelle Medical Unlimited Company, EL(25)A/41
Source: MHRA/Gov.uk 21.8.25 Chanelle Medical Unlimited Company has informed the MHRA of an error with the European Article Number (EAN) / Global Trade Item Number (GTIN) barcode on certain batches...
Class 4 Medicines Defect Notification: Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited, UK, EL(25)A/40
Source: MHRA/Gov.uk 14.08.2025 Accord Healthcare Limited, UK has informed the MHRA that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) do not contain all the required...
Class 4 Medicines Defect Notification: Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution, Zydus Pharmaceuticals UK Ltd, EL(25)A/39
Source: MHRA/Gov.uk 07.08.2025 Zydus Pharmaceuticals UK LTD has informed the MHRA that there is an error on the artwork for the outer carton and Patient Information Leaflet (PIL) of Topiramate...
Class 2 Medicines Recall: Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma, EL(25)A/38
Source: MHRA/Gov.uk 04.08.2025 LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing. DMRC reference number DMRC-36306427...
Class 4 Medicines Defect Notification: Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV, EL(25)A/37
Source: MHRA/Gov.uk 31.7.25 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....
Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator, Becton Dickinson UK Ltd, EL(25)A/36
Source: MHRA/Gov.uk 28.7.25 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...
Class 2 Medicines Recall: Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension , CD Pharma Ltd, EL(25)A/35
Source: MHRA/Gov.uk 24.7.25 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...
Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)
Source: MHRA/Gov.uk 22.7.25 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...
Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
Source: MHRA/Gov.uk 9.7.25 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...
