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List of Field Safety Notices from 19 to 23 February 2024
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Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in th…
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List of Field Safety Notices from 5 to 9 February 2024.
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List of Field Safety Notices from 12 to 16 February 2024
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Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
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Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high related substances test results after their release to the marke…
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List of Field Safety Notices from 29 January to 2 February 2024.
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Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD).
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Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.
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List of Field Safety Notices (FSNs) from 22 to 26 January 2024.
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Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Cres…
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List of Field Safety Notices (FSNs) from 15 to 19 January 2024.
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USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain a low volume of solution; less than the label claim of 2 ml.
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List of Field Safety Notices from 8 to 12 January 2024.
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List of Field Safety Notices from 1 to 5 January 2024.
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List of Field Safety Notices from 25 to 29 December 2023
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Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets.
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List of Field Safety Notices from 18 to 22 December 2023
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List of Field Safety Notices from 11 to 15 December 2023
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Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability.
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Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.
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Field Safety Notices from 4 to 8 December 2023.
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Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets.
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Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Tramadol Hydrochloride 50mg Capsules, Hard.
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Field Safety Notices from 27 November to 1 December 2023
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Teva UK Ltd. has informed the MHRA of a labelling error. This notification provides further advice on the safe use of the product.
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AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further advice on the safe use of the product up to the amended expiry date.
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List of Field Safety Notices (FSNs) from 20 to 24 November 2023
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The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advic…
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Specific batches of carbomer gel are being recalled as a precaution due to possible
microbiological contamination.
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List of Field Safety Notices from 13 to 17 November 2023.
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List of Field Safety Notices from 6 to 10 November 2023.
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List of Field Safety Notices from 30 October to 3 November 2023.
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List of Field Safety Notices from 23 to 27 October 2023.
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List of Field Safety Notices from 16 to 20 October 2023.
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Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.
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List of Field Safety Notices from 9 to 13 October 2023.
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The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as the cap, if not removed, can easily get dislodged and become stuck in…
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List of Field Safety Notices from 25 to 29 September 2023.
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Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product.
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List of Field Safety Notices from 18 to 22 September 2023.
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Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stab…
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List of Field Safety Notices from 11 to 15 September 2023.
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List of Field Safety Notices from 4 to 8 September 2023
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Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion.
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List of Field Safety Notices (FSNs) from 28 August to 1 September 2023.
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Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above are missing information relating to…
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Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 a…
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The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing.
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Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.