Archive for MHRA Updates
Class 4 Medicines Defect Information: Kent Pharma UK, Paracetamol 500mg Effervescent Tablets, EL(24)A/49
Source: MHRA/ Gov.uk 21.10.24 DMRC reference number DMRC-32772688 Company name Kent Pharma UK Paracetamol 500mg Effervescent x100 Tablets (P), PL 51463/0031 SNOMED Codes 1856211000001101 (5×20) 1856011000001106 (10×10) Paracetamol 500mg Effervescent...
Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 mg film-coated tablets, EL(24)A/48
Source: MHRA/Gov.uk 10.10.24 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 Linezolid 600...
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46
Source: MHRA/Gov.uk 3.10.24 Glenmark Pharmaceuticals Europe Ltd is recalling the affected batches as a precautionary measure due to out of specification results for unknown impurities during routine stability testing and...
Class 4 Medicines Defect Information: Sandoz Ltd., Rosuvastatin 20mg, 40mg Tablets, EL(24)A/45
Source: MHRA/Gov.uk 1.10.24 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 Rosuvastatin 20mg...
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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to...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...