Archive for MHRA Updates
Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Sabril 500 mg film-coated tablets & Sabril 500 mg granules for oral solution, EL(23)A/25
Source: MHRA / Gov.uk Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in...
Class 4 Medicines Notification, Cipla (UK) Limited and Pharmathen S.A., Various Products, EL(23)A24
Source: MHRA / Gov.uk 13.7.23 Cipla (EU) Limited, UK and Pharmathen S.A. have informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are...
Class 3 Medicines Recall: Strandhaven Limited T/A Somex Pharma, Sildenafil 100mg Film-coated Tablets, EL(23)A/21
Source: DHSC 3.7.23 Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of...
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...
