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Summary of the latest safety advice for medicines and medical device users
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Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.
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Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.
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Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testin…
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Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.
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Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
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Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD).
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The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing.
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The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
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Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille…
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B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
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This alert highlights the Adult Renal Association Clinical Practice Guidelines (2020) recommendation on calcium gluconate use to support organisations to update local policies and guidelines for the treatment of severe hyper…
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Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.
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Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.
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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.
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List of Field Safety Notices (FSNs) from 21 to 25 November 2022
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Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.
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Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL).
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Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution
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hameln pharma ltd is initiating a recall of batch 210505 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure
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Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples.
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Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
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hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure.
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Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label.
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Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa…
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The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia.
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Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.
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Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution (>…
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Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit.
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Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.
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Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.
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Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices.
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Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity.
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Zentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for …
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Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.
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BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.
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Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.
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Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…
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Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of…
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Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.
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Manufactured by Abbott – cases of valvular insufficiency and early revision.
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Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.
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The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.
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Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.
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Manufactured by Flexicare Medical – loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.
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Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.
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Manufactured by Baxter – Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown.
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GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.
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Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.
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Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.