Archive for MHRA Updates
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of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution....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MHRA that the Patient Information Leaflet (PIL) packaged in certain batches of Zestoretic 20mg/12.5mg Tablets contains outdated safety information.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...
Hundreds of thousands of women experiencing menopause symptoms to get cheaper HRT
Source: Department of Health and Social Care, Maria Caulfield MP, and The Rt Hon Steve Barclay MP 21.2.22 Around 400,000 women across England will get better access to menopause support – saving...
NexGen Knee replacement: affected patients should be offered additional follow up, DSI/2023/003
Source: MHRA/Gov.uk 15.2.23 The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral...
National Patient Safety Alert: NIDEK EyeCee One preloaded and EyeCee One Crystal preloaded Intraocular Lenses (IOLs): risk of increased intraocular pressure (NatPSA/2023/003/MHRA)
Source: MHRA / Gov.uk 1.2.23 The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses...
