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Nova Laboratories Limited (MS 13581) is recalling specific batches of the impacted products due to a potential risk of contamination.
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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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Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 21 to 25 June 2021.
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Philips have issued 2 FSNs about selected ventilators and CPAP and BiPAP devices.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 14 to 18 June 2021.
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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 鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 June 2021.
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The importer and distributor of the above products (Eaststone Limited) has informed us of reports that two affected batches may be contaminated with mould.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 31 May to 4 June 2021.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 24 to 28 May 2021.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 17 to 21 May 2021.
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Advanz Pharma is recalling batches of carbimazole tablets due to an out of specification observation for tablet appearance of samples during routine stability testing.
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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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Advanced Accelerator Applications (UK & Ireland) Ltd is recalling a specific batch as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 10 to 14 May 2021
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AstraZeneca UK Limited is recalling the above batch of Bricanyl 0.5mg/ml solution for injection or infusion as a precautionary measure due to out of specification results for a routinely tested known impurity during stabilit鈥�
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Recommendations for clinicians including not implanting these devices
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Summary list of field safety notices (FSNs) from medical device manufacturers from 3 to 7 May 2021
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Summary list of field safety notices (FSNs) from medical device manufacturers from 26 April to 30 April 2021
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Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to 鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 19 April to 23 April 2021
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Ennogen Pharma Limited are recalling an affected batch of Trimethoprim 200mg Tablets as a precautionary measure due to the observation of a foreign tablet, which is identified as Trimethoprim 100mg Tablet.
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Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 12 April to 16 April 2021
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Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 2021
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Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor.
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List of field safety notices (FSNs) from medical device manufacturers from 29 March to 02 April 2021.
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List of field safety notices (FSNs) from medical device manufacturers from 22 March to 26 March 2021.
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There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles
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List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 March 2021.
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Macarthys Laboratories Limited T/A Martindale Pharma has informed us that the EAN barcode on the outer carton of a specific batch of Caffeine Citrate 10mg/ml Solution for Injection is incorrect.
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List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 March 2021
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Thame Laboratories are recalling the above batches due to an issue with the container closure (child-resistant cap).
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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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Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).
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List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 March 2021
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The MHRA has made further changes to the way we issue safety messaging to healthcare providers.
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List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 February 2021
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Orion Corporation T/A Orion Pharma (UK) Ltd are recalling specific batches as a precautionary measure due to an issue related to moulding defects in the bulk chambers where the inhalation powder is stored.
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Unknown risks following distribution of product after CE certificate withdrawal
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List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 2021
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SyriMed are recalling the below batch as a precautionary measure due to an issue related to the container closure (child-lock cap).
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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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List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 February 2021
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Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5碌m sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-鈥�
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List of field safety notices (FSNs) from medical device manufacturers from 01 to 05 February 2021
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Gr眉nenthal Ltd has informed us of a potential microbial contamination during routine stability testing for the batches listed in this recall.
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Intrapharm Laboratories Ltd has informed us that they have received complaints that the consistency of a batch of Kolanticon Gel 500ml is lumpy. An investigation and retained samples for this batch show the same homogeneity 鈥�