Archive for MHRA Updates
Class 2 Medicines Recall: Pfizer Limited, Oxbryta 500mg Tablets (voxelotor), EL(24)A/44
Source: MHRA/ Gov.uk 30.9.24 Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to...
Class 4 Medicines Defect Information: Sandoz Ltd., Risperidone 1mg, 2mg, 3mg Tablets, EL(24)A/43
Source: MHRA/Gov.uk 26.9.24 Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg,...
Class 3 Medicines Recall: Orion Pharma (UK) Ltd, Eldepryl 5mg Tablets (selegiline), EL(24)A/42
Source: MHRA/ Gov.uk Orion Pharma (UK) Ltd is recalling this batch as a precautionary measure due to an out of specification result in the assay result during the follow up...
Class 3 Medicines Recall: Theramex HQ UK Ltd, Evorel Sequi, EL (24)A/41
Source: MHRA / Gov.uk 12.9.24 Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that...
Philips Respironics BiPAP A series ventilators……
Source: MHRA /Gov.uk 28.824 Alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006. Philips Respironics has issued a Field Safety Notice (FSN) relating to the...
Class 4 Medicines Defect Information: Chemidex Pharma Ltd, Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid), EL(24)A/40
Source: MHRA/ Gov.uk 27.8.24 Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables for Ponstan 250mg...
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Fingolimod 0.5 mg Hard Capsules, EL(24)A/39
Source: MHRA / Gov.uk 19.8.24 Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results. MDR number MDR 113-05/23 Company name Glenmark Pharmaceuticals Europe Ltd...
Class 2 Medicines Recall: Strides Pharma UK Limited, Loperamide Hydrochloride Capsules 2mg, EL(24)A/38
Source: MHRA / Gov.uk 15.8.24 Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during...
Class 4 Medicines Defect Information: Dawa Limited, Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution EL (24)A/37
Source: MHRA / Gov.uk 14.8.24 Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone...
Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml
Source: MHRA / Gov.uk 12.8.24 Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral...
Class 3 Medicines Recall: Accord-UK Ltd, Trandolapril 0.5mg, 2mg, 4mg Capsules
Source: MHRA / Gov.uk 8.8.24 Trandolapril 0.5mg, 2mg, 4mg Capsules, EL(24)A/35 Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results. MDR reference number MDR 113-05/24...
Four concession prices for July rolled over to August!
The Department of Health and Social Care has agreed that 4 concessionary prices granted in July 2024 will be rolled over for August 2024. And not as printed in the...
