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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.
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Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to the product appearance.
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The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
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List of Field Safety Notices (FSNs) from 21 to 25 August 2023.
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Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a…
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List of Field Safety Notices (FSNs) from 14 to 18 August 2023.
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Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.
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Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.
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Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille…
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medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
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List of field safety notices (FSNs) from medical device manufacturers from 7th August to 11th August 2023.
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List of field safety notices (FSNs) from medical device manufacturers from 31 July to 4 August 2023.
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The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.
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List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 July 2023
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B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 July 2023.
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medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.
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List of Field Safety Notices (FSNs) from 10 to 14 July 2023
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The company has informed us that the consistency of the product within the batches has a reduced viscosity and more closely resembles a lotion than a cream.
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Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer for vigabatrin.
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Cipla (EU) Limited, UK and Pharmathen S.A. have informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medic…
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List of Field Safety Notices (FSNs) from 3 to 7 July 2023
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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.
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List of Field Safety Notices (FSNs) from 26 to 30 June 2023
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medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation …
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Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of 4 tablets.
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List of Field Safety Notices (FSNs) from 19 to 23 June 2023
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This alert highlights the Adult Renal Association Clinical Practice Guidelines (2020) recommendation on calcium gluconate use to support organisations to update local policies and guidelines for the treatment of severe hyper…
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List of Field Safety Notices (FSNs) from 12 to 16 June 2023.
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List of Field Safety Notices (FSNs) from 5 to 9 June 2023.
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List of Field Safety Notices (FSNs) from 29 May to 2 June 2023
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List of Field Safety Notices (FSNs) from 22 to 26 May 2023
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The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
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Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap.
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List of Field Safety Notices (FSNs) from 15 to 19 May 2023
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Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.
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The MHRA is issuing updated advice that Philips Respironics V60 and V60 Plus non-invasive ventilators must be permanently removed from use.
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Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm i…
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List of Field Safety Notices (FSNs) from 8 to 12 May 2023
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List of Field Safety Notices (FSNs) from 1 to 5 May 2023
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Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.