Archive for MHRA Updates
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Source: MHRA/ Gov.uk 10.12.25 Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the...
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Source: MHRA/ Gov.uk 27.11.25 Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the...
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Source: MHRA/ Gov.uk 25.11.25 Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important...
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
Source: MHRA/Gov.uk 20.11.2025 Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on...
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Source: MHRA 11.11.25 Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing...
Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
Source: MHRA 10.11.25 Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing. DMRC reference number...
Class 4 Medicines Defect Notification: Relonchem Ltd, Various Products, EL(25)A/44
Source: MHRA/Gov.uk 23.10.2025 Relonchem Ltd has informed the MHRA that duplicate GTIN numbers have been assigned to certain Losartan potassium/Hydrochlorothiazide coated tablets in error and a duplicate EAN number has...
Class 3 Medicines Recall: Accord Healthcare Ltd, Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution, EL(25)A/45
Source: MHRA/Gov.uk 23.10.2025 Accord Healthcare Ltd is recalling a batch of Ipratropium Bromide 500 microgram/2ml Nebuliser Solution after a foil pouch was found to contain ampoules with incorrect labels...
BD BodyComm™ version 3.3 software used for BodyGuard infusion pumps, BodyGuard-T and T34 syringe drivers: Important steps to manage transition to Windows 11 (DSI/2025/006)Class 4 Medicines Defect
Source: MHRA/Gov.uk 07.10.2025 he BodyComm software currently uses Windows 10. Microsoft is transitioning to Windows 11 from 14 October 2025 which requires an updated cable to connect the pumps to...
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...
