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Kyowa Kirin Services Ltd. are recalling a batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets as a…
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Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches.
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 February 2022.
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medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.
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The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.
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The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold wit…
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Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 February 2022.
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hameln pharma ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification
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Mawdsley-Brooks & Company Limited (UK importer) is recalling a specific batch of this product as a precautionary measure due out of specification result for pH that was identified during routine stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 31 January to 4 February 2022.
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Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.
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Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.
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List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 January 2022.
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Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.
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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 January 2022.
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SANTEN Oy (trading as Santen UK Limited) are recalling the above 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 10 to 14 January 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 January 2022
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List of field safety notices (FSNs) from medical device manufacturers from 29 to 31 December 2021
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Dermaved is recalling the above product from patients due to presence of clobetasol propionate (0.001% w/w).
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List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 December 2021
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Error relating to the stated alcohol content for batches of Benylin Chesty Coughs Original (P) and Benylin Chesty Coughs Non-Drowsy (GSL), supplied by McNeil Products Limited
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Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk of the device breaking in use.
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List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 December 2021
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One batch is being recalled due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing.
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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 December 2021
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Novartis Pharmaceuticals UK are recalling the above batch due to a faulty plunger stopper which has led to an increased number of customer complaints relating to the plunger being difficult to press down. The faulty plunger …
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Intrapharm Laboratories Ltd are recalling the above batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for related substances obtained during stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 29 November to 3 December 2021
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Following our latest review of medical device alerts, we have archived the ones listed below.
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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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List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 November 2021
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Error relating to the wording on the outer carton label for Mometasone Furoate 50 Microgram / Dose Nasal Spray, supplied by PilsCo Ltd.
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Error with the patient information leaflet (PIL) that has been provided with Diuril Oral Solution, supplied by Mawdsley-Brooks & Company Limited.
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List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 November 2021
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Residue particles can end up in the patient’s eye.
For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices.
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Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets.
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SANTEN Oy (trading as Santen UK Limited) are recalling the above batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.
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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