Archive for MHRA Updates
Class 4 Medicines Notification: Irbesartan 150 mg and 300 mg film-coated tablets, EL(25)A/02
Source: MHRA / Gov.uk 13.1.25 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...
Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01
Source: MHRA 9.1.25 Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets...
UK medicines regulator warns against buying weight loss medicines without a prescription this New Year
Source: MHRA 30.12.24 The MHRA’s Criminal Enforcement Unit works to identify and prevent the illegal sale of weight-loss medicines online. The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding...
Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63
Source: MHRA/Gov.uk 19.12.24 Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to...
Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder, EL(24)A/62
Source: MHRA/Gov.uk 9.12.24 Wockhardt UK Limited is recalling this batch as a precautionary measure following the identification of a low number of units which may have a defect in the...
Class 4 Medicines Defect Information: Brillpharma Limited, Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, EL(24)A/61
Source: MHRA/Gov.uk 4.12.24 L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5...
Class 3 Medicines Recall: Kent Pharma UK, Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free, EL (24)A/60
Source: MHRA/Gov.uk 3.12.24 Kent Pharma UK is recalling a batch of phenoxymethylpenicillin 250mg/5mL oral solution sugar free due to a low phenoxymethylpenicillin assay DMRC reference number DMRC-31179592 Company name Kent...
Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Limited, Mycophenolate Mofetil 1g/5ml Oral Suspension, EL(24)A/59
Source: MHRA/Gov.uk 2.12.24 Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw...
Class 4 Medicines Defect Information: Strides Pharma UK Ltd, Liothyronine Sodium 5 & 20 micrograms Tablets, EL(24)A/58
Source: MHRA/Gov.uk 28.11.24 Strides Pharma UK Ltd has informed MHRA of an error in the patient information leaflet (PIL) for Liothyronine Sodium 20 micrograms Tablets and Liothyronine Sodium 5 micrograms...
Class 4 Medicines Defect Information: Morningside Healthcare Limited
Source: MHRA/Gov.uk 27.11.24 Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, EL(24)A/57 Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in...
Class 3 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(24)A/56
Source: MHRA/Gov.uk 25.11.24 Syri Limited, T/A SyriMed is recalling this batch of product as a precautionary measure due to crystallisation observed over time in the oral solution. DMRC reference number...
Class 4 Medicines Defect Information: Takeda UK Limited, Entyvio 108mg solution for injection in pre-filled syringe, EL(24)A/55
Source: MHRA/ Gov.uk 18.11.24 Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet for specified batches of Entyvio 108mg pre-filled syringes. DMRC...
