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[Archived] Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.
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[Archived]Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump
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Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).
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Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.
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Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
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Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018
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List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018
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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
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Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
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Cadiasun Pharma GmBH has informed us that there is an error on the patient information leaflet for Caspofungin 70mg powder for concentrate for solution for infusion.
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UK update on Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
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IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
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Rosemont Pharmaceuticals Limited, MS 427 is issuing a company-led drug alert for an unlicensed medicine Phenytoin 90mg/5ml Oral Suspension (CLDA (18)A/02).
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FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)
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Caution in Use: Distribute to Pharmacy and Clinic Level.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018
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Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (MDA/2018/008).
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Caution in Use - Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level. (EL (18) A/05)
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Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)
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Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL…
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Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
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The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
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Caution in Use: Distribute to Pharmacy, Hospital, GP, Dental Practice, Ward and Clinic Level.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.
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Pfizer is recalling the above batches as a precaution due to an out of specification result for microbiological testing during routine stability studies on a batch of the product which was not released to the market. (EL (17…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
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Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.
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Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.
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Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the…
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MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)
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Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.
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Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.
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Manufactured by Zimmer Biomet - recall due to increased risk of fracture for all titanium trays manufactured before September 2011 and distributed in the UK between September 2010 and January 2017.
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Strides Pharma UK Ltd, trading as Co-pharma, is recalling specific batches of Diclo-SR 75 Tablets as a precautionary measure
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Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle
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Action Within 48 Hours. Wholesaler and Pharmacy Level Recall. Teva UK Limited is recalling batches due to out of specification results for impurities obtained during routine stability testing.
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Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038
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(CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)
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[Archived] (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)
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(Novartis Consumer Health UK Limited and Actavis Group PTC EHF): Product reclassified from P to POM due to safety concerns – class 2 action within 48 hours (EL (15)A/01)