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Guerbet Laboratories Ltd is recalling the above batches of Dotarem 10ml vials due to the potential risk of a sterility break.
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List of field safety notices (FSNs) from medical device manufacturers from Field Safety Notices: 8 to 12 November 2021
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Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the below batches of products.
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Perrigo are recalling the above batches of Cold & Flu Relief Capsules (GSL) – Various Liveries, due to an error on the leaflet and carton for the products as noted below.
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Following our latest review of medical device alerts, we have archived the ones listed below.
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List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 November 2021
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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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Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches are missing important safety relevant text changes.
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List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 October 2021
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Aspire Pharma Limited is recalling the below batches of Bimatoprost Aspire 0.3mg/ml eye drops, solution in single dose container 0.4ml x 30 as a precautionary measure.
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List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 October 2021
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Qualasept Ltd t/a Bath ASU is recalling a specific batch of Irinotecan 200mg/260mL in sodium chloride 0.9% w/v intravenous infusion and specific batches of Infliximab (Remsima) Intravenous infusion in Sodium C…
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Pfizer Ltd are recalling all in-date batches of Champix (varenicline) as a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake. This recall also includes Parallel Imp…
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Perrigo are recalling batches of Tesco Flu-Max All In One Chesty Cough & Cold Powder due to an error on the sachet contained within the outer carton.
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Following our latest review of medical device alerts, we have archived the ones listed below.
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List of field safety notices (FSNs) from medical device manufacturers from 27 September to 01 October 2021
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East Suffolk and North Essex NHS Foundation Trust (MS 12882) is recalling specific batches of Glucose 10%w/v injection 10mL and Trometamol 7%w/v injection 5mL due to limited assurance of product sterility.
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List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 September 2021
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Accord-UK Ltd (Trading style: NorthStar) are recalling the above batch of product as a precautionary measure due to tablet hardness failures, leading to crumbling and breaking tablets.
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List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 September 2021
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SANTEN Oy (trading as Santen UK Limited) are recalling two batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.
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List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 September 2021
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Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.
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List of field safety notices (FSNs) from medical device manufacturers from 30 August to 3 September 2021.
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Following our latest review of medical device alerts, we have archived the ones listed below.
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List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 August
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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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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 August
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List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 August
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List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 August
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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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Summary list of field safety notices (FSNs) from medical device manufacturers from 26 to 30 July 2021
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Summary list of field safety notices (FSNs) from medical device manufacturers from 19 to 23 July 2021.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 16 July 2021.
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Brown & Burk UK Limited have noticed an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension. The product information incorrectly states the quantity of the excipient sodium benzoa…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 5 to 9 July 2021.
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Napp Pharmaceuticals Limited have noticed and an error in the PIL of specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets.
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Galderma UK identified an error regarding an older version of artwork being used and packed with specific batches of Tetralysal 300mg Hard Capsules.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 28 June to 2 July 2021.
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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…
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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.