Archive for MHRA Updates
Class 4 Medicines Defect Information: Chelonia Healthcare Limited, Propantheline Tablets 15mg (Genesis Pharmaceuticals livery), EL(24)A/27
Source: MHRA / Gov.uk 9.7.24 Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the...
Class 2 Medicines Recall: Kent Pharma UK, Itraconazole 10mg/ml Oral Solution, EL(24)A/26
Source: MHRA / Gov.uk 4.7.24 Kent Pharma UK is recalling various batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of...
Class 3 Medicines Recall: Accord Healthcare Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules, EL(24)A/25
Source: MHRA/Gov.uk 2.7.4 Accord Healthcare Ltd is recalling various batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed...
Class 4 Medicines Defect Information: PHARMATHEN S.A., Grepid 75 mg film coated tablets (Kent Pharma Livery), EL(24)A/24
Source: MHRA / Gov.uk 24.6.24 PHARMATHEN S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75mg film coated tablets is missing the medicines legal...
Class 3 Medicines Recall: Teva UK Limited, GoResp Digihaler, EL (24)A/23
Source: MHRA / Gov.uk 18.6.24 Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate)...
Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets, EL (24)A/22
Source: MHRA / Gov.uk 17.6.24 Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg...
Class 4 Medicines Defect Information: Dawa Limited, Paracetamol 500mg, 1000mg Film-Coated Tablets, EL (24)A/21
Source: MHRA/Gov.uk 10.6.24 Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL). MDR number MDR 312-04/24...
Class 2 Medicines Recall: Desitin Pharma UK Ltd, Lamotrigine Desitin 10mg/ml Oral Suspension, EL(24)A/20
Source: MHRA/Gov.uk 7.6.24 Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the...
Class 3 Medicines Recall: Neuraxpharm UK Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules, EL(24)A/19
Source: MHRA / Gov.uk 5.6.24 Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after...
Class 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment, EL(24)A/18
Source: MHRA/ Gov.uk 3.6.24 Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table. MDR number MDR...
Class 4 Medicines Defect Information: Fresenius Kabi Limited, Sodium Chloride 0.9% Intravenous Infusion BP (Freeflex and Freeflex Plus), EL (24)A/17
Source: MHRA / Gov.uk 22.5.24 Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS. MDR...
Class 3 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15
Source: MHRA / Gov.uk 22.5.24 The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the...
