Archive for MHRA Updates
Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Tramadol Hydrochloride 50mg Capsules, Hard, EL (23)A/41
Source: MHRA / gov.uk 6.12.23 Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed...
Class 4 Medicines Notification: Teva UK Ltd., Caramet 25/100mg CR Tablets, EL(23)A/40
source: MHRA / Gov.uk 4.12.23 Teva UK Ltd. has informed the MHRA of a labelling error. This notification provides further advice on the safe use of the product. MDR number...
Class 3 Medicines Recall: AstraZeneca UK Ltd., Fluenz Tetra nasal spray suspension, EL(23)A/39
Source: MHRA / Gov.uk 30.11.23 AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further...
National Patient Safety Alert: Valproate:
Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA) Source: MHRA/ Gov.uk 28.11.23 The MHRA is asking organisations to...
Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection, DSI/2023/11
Source: MHRA/ Gov.uk Specific batches of carbomer gel are being recalled as a precaution due to possible microbiological contamination. Devices Details Device Name: AACARB eye gel, AACOMER eye gel and PUROPTICS...
Treatment with isotretinoin for patients under 18 must be approved by two prescribers, under new MHRA rules
Source: MHRA 31.10.23 New measures strengthen the safe use of the acne drug isotretinoin for patients across the UK, following a patient-focused expert review The UK Medicines and Healthcare products...
#MedSafetyWeek 2023 (6-12 November)
Source: MHRA #MedSafetyWeek is a social media campaign that takes place annually usually in November and each year there is a different focus or theme to encourage the reporting of...
Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38
Source: MHRA/Gov.uk 23.10.23 Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information. MDR number...
Falsified Ozempic (semaglutide) pens identified at two wholesalers in the UK
Source: MHRA 18.10.23 No evidence of supply or harm to patients The Medicines and Healthcare products Regulatory Agency (MHRA) has today (18 October 2023) confirmed that pre-filled pens falsely labelled...
SteriFeed Colostrum Collection device and risk of choking due to infant airway occlusion, DSI/2023/010
Source: MHRA/Gov.uk 10.10.23 The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as...
Class 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules, EL (23)A/37
Source: MHRA /Gov.uk 27.9.23 Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product. MDR number MDR...
Class 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36
Source: MHRA/ Gov.uk 20.9.23 Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the...
