Archive for MHRA Updates
Consultation on a new Code of Practice for the Expert Advisory Committees
Source: MHRA & Commission on Human Medicines We are consulting on a set of proposals to improve and strengthen the Code of Practice for experts who provide advice on which...
Class 4 Medicines Defect Information: Pfizer Limited, Depo-Medrone with Lidocaine 40 mg/mL (1 mL and 2 mL vials – single vial preparations), EL (22)A/18
Source: MHRA 21.4.22 Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the specific batches mentioned...
Upcoming Spring Tutorials!
Please note, it is not essential to attend course parts in order, as they have been designed to be stand-alone sessions and the full learning benefit will still be achieved. Non-members...
Class 2 Medicines Recall: USV UK Limited, Olopatadine USV 1mg/ml Eye Drops, Solution, EL(22)A/17
Source: MHRA / Gov.uk 11.4.22 USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing....
Class 2 Medicines Recall: USV UK Limited, Olopatadine USV 1mg/ml Eye Drops, Solution, EL(22)A/17
Source: MHRA / Gov.uk – 11 April 2022 USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during...
Upcoming Spring Tutorials- Secure your places!
Please note, it is not essential to attend course parts in order, as they have been designed to be stand-alone sessions and the full learning benefit will still be achieved. Non-members...
National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA)
Source: MHRA / Gov.uk 29.3.22 Philips Health Systems informed have identified an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators....
Class 2 Medicines Recall: Pfizer Limited, Accuretic 10/12.5 mg film-coated tablets, EL (22)A/16
Source: MHRA / Gov.uk 23.3.22 Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit. Company name Pfizer...
Class 4 Medicines Defect Information: Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder and solvent for suspension for injection, EL (22)A/15
Source: MHRA / Gov.uk 17.3.22 Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack....
Company led medicines recall: Advanced Accelerator Applications NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine], CLMR (22)A/02
Source: MHRA / Gov.uk 16.3.22 Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during...
Class 4 Medicines Defect Information, Ayrton Saunders Limited, Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries), EL (22)A/14
Source: MHRA/ Gov.uk 15.3.22 Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons. MDR Number MDR 087-03/22 Company name Ayrton Saunders Limited Product description...
Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL (22)A/13
Source: MHRA / Gov.uk 14.3.22 CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on...
