Archive for MHRA Updates
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...
Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, GONAPEPTYL Depot 3.75mg, Powder and solvent for suspension for injection, EL(23)A/12
Source: MHRA /Gov.uk 23.3.23 Ferring Pharmaceuticals Limited is recalling certain batches of GONAPEPTYL Depot 3.75mg due to a defect noticed in the seal of the needle wrapping for the CE-marked...
Class 3 Medicines Recall: Rosemont Pharmaceuticals Limited, Sildenafil 10mg/ml Oral Suspension, EL(23)A/11
Source: MHRA / Gov.uk 21.3.23 Rosemont Pharmaceuticals Limited has informed the MHRA that the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) in the batch listed above is...
HRT on Pre-Payment Certificates (PPC)
From 1 April 2023, women prescribed HRT – the main treatment for menopause symptoms – will have access to a new scheme enabling access to a year’s worth of menopause...
Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09
Source: MHRA 15.3.23 Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution....
Class 4 Medicines Defect Information: Drugsrus Limited, Clexane 10,000 IU (100mg) / 1ml Syringes, EL(23)A/08
Source: MHRA / Gov.uk 9.3.23 Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical...
Class 4 Medicines Defect Information: Thornton & Ross Ltd, Methadone 1mg/mL Oral Solution BP – Sugar Free, Methadone Mixture 1mg/ml , EL(23)A/07
Source: MHRA/ Gov.uk 7.3.23 Thornton & Ross Ltd has informed the MHRA that specific batches of Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml, have been packaged...
Class 2 Medicines Recall: Teva UK Limited, Levothyroxine 12.5mcg Tablets, EL (23)A/06
Source: MHRA/ Gov.uk Teva UK Limited is recalling one batch of Levothyroxine 12.5mcg Tablets in response to a lower than required assay result discovered during routine stability testing. MDR number...
Class 4 Medicines Defect Information: Atnahs Pharma UK, Zestoretic 20mg/12.5mg Tablets, EL (23)A/05
Source: MHRA 27.2.23 Atnahs Pharma UK has informed the MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information. MDR number...
Class 4 Medicines Defect Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04
Source: MHRA/Gov.uk 22.3.23 Reckitt Benckiser Healthcare (UK) Limited has informed the MHRA that a typographical error has been identified on the end flap of the outer carton of some batches...
