Archive for MHRA Updates
National Patient Safety Alert: Potential risk of underdosing with calcium gluconate in severe hyperkalaemia (NatPSA/2023/007/MHRA)
Source: MHRA 27.6.23 Date of issue: 27 June 2023 Reference No: NatPSA/2023/007/MHRA This alert is for action by: Acute providers, specifically those providing acute medical care where severe hyperkalaemia is...
Class 3 Medicines Recall: Tricodent Limited (supplier), Medical Oxygen B.P (MEDIGAS OXYGEN B.P), EL (23)A/20
Source: MHRA/Gov.uk 6.6.23 The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK. MDR number MDR 053-04/23 Company name Tricodent...
National Patient Safety Alert: Removal of Philips Health Systems V60 and V60 Plus ventilators from service: risk of shutdown leading to complete loss of ventilation (NatPSA/2023/005/MHRA)
Source: MHRA/Gov.uk 18.5.23 The MHRA is issuing updated advice that Philips Respironics V60 and V60 Plus non-invasive ventilators must be permanently removed from use. Date of issue: 18 May 2023...
Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion, EL (23)A/17
Source: MHRA / Gov.uk 16.5.23 Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may...
Class 3 Medicines Recall: Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial, EL(23)A/16
Source: MHRA /Gov.uk 10th May 2023 Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification. MDR number MDR 002-05/23 Company...
National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure, NatPSA/2023/004/MHRA
Source: MHRA / Gov.uk Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors. National Patient Safety Alert Reference...
Class 4 Medicines Defect Information: Omega Pharma Ltd, Beconase Hayfever Nasal Spray, EL (23)A/15
Source: MHRA / Gov.uk 26.4.23 Omega Pharma Ltd has identified that there is text missing in Section 2 of the Patient Information Leaflet (PIL) in packs of Beconase Hayfever Nasal...
Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension, EL (23)A/14
Source: MHRA / Gov.uk Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’...
Company led medicines recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04
Source: MHRA / Gov.uk The importer and distributor of the above products has informed us of reports that the microbial limit for Total Microbial Aerobic Count (TAMC) has been tested...
Company led medicines recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04
Source: MHRA 20.4.23 The importer and distributor of the above products has informed us of reports that the microbial limit for Total Microbial Aerobic Count (TAMC) has been tested to...
Dispex Highlights Key Points for HRT on PPC
Source materials: DHSC We have read through the Department of Health & Social Care’s Guidance on the Hormone Replacement Therapy prescription prepayment certificate, and have highlighted the key points to...
Class 4 Medicines Defect Information: Ethigen Limited, Briviact 75mg & 100mg film-coated tablets, EL(23)A/13
Source: MHRA 30.3.23 Ethigen Limited have informed the MHRA that the Patient Information Leaflet (PIL) in Briviact 75mg and Briviact 100mg film coated tablets contains incorrect or missing information. MDR...
