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Crescent Pharma Limited are recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 April 2022
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Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the specific batches mentioned in this notification.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 April 2022
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Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 April 2022
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USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.
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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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List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 March 2022.
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Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 March 2022.
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Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.
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Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 March 2022.
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Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.
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CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.
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Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.
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List of field safety notices (FSNs) from medical device manufacturers from 28 February to 4 March 2022.
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Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 February 2022.
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Kyowa Kirin ÌìÃÀÓ°Ôº 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 …