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List of field safety notices (FSNs) from medical device manufacturers from 20 January to 24 January 2020
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Caution in Use: Distribute to Pharmacy level. Advanz Pharma has informed us of a discrepancy on the product packaging. The discrepancy relates to “capsules” printed at the top right of the packs in error, instead of tablets
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Hospira UK Limited (Pfizer) is recalling specific batches as a precautionary measure.
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Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
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Accord Healthcare are recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerede Adrenaline Autoinjectors after identifying an error than can cause some pens to fail to activate.
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M&A Pharmachem Limited is recalling all unexpired batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination.
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OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
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Creo Pharma Limited and Tillomed Laboratories Limited are recalling all unexpired stock of the products listed in this alert.
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 November 2019.
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Accord-UK Ltd has informed us of an issue related to decommissioning of the batch below.
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Sandoz Limited is recalling one batch due to the occurrence of degradation in some vials, resulting in green discoloration of the powder in the vial, leading to increased levels of impurities/degradation products in the medi…
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This recall affects Mitomycin-C Kyowa 2 mg (PL 16508/0042), 10 mg (PL 16508/0043), 20 mg (PL 16508/0044), powder for solution for injection, and Mitomycin-C Kyowa 40 mg (PL 16508/0045), powder for intravesical solution.
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M & A Pharmachem is recalling specific batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination
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Biogen Idec UK is recalling batches as a precautionary measure due to a manufacturing issue.
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Omega Pharma Limited and Galpharm International Limited are recalling unexpired stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
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Rosemont Pharmaceuticals Limited is recalling unexpired stock from pharmacies as a precautionary measure due to possible contamination with an impurity.
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Teva UK Limited trading as ratiopharm GmbH is recalling all unexpired stock of Ranitidine Effervescent Tablets from pharmacies.
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Alliance Pharmaceuticals Ltd has informed the MHRA that there are possible side effects not reported on the Patient Information Leaflet.
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Aventis Pharma Limited t/a Sanofi has informed the MHRA that a change to the Patient Information Leaflet concerning possible side effects for Rifadin (rifampicin) 150mg Capsules has not been implemented by the required timel…
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GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.
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The MHRA has notified Bausch and Lomb UK Limited of reports that Emerade pens have failed to activate. The MHRA is advising that Emerade devices should not be recalled.
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Martindale Pharmaceuticals Limited is recalling the above batch due to an issue with homogeneity.
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Dr. Reddy's Laboratories (UK) Ltd is recalling the above batch due to the potential for small particles of Aripiprazole active material to be present which may affect the efficacy of the product.
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Accord-UK Ltd is recalling the above batches due to the potential for small particles of Aripiprazole active material to be present which may affect the efficacy of the product. No relevant product complaints or adverse reac…
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Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.
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Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.
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Chanelle Medical is recalling the above batch because a small number of packs have been found to contain tablets which are stuck together, with mould observed on some tablets. The mould has been identified as a Penicillium s…
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.
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Martindale Pharma has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the EAN bar code for the following batches is incorrect.
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Medicines have been taken out of the regulated medicines’ supply chain during distribution. The products have been parallel imported into the UK by B & S Healthcare from Italy and have been re-labelled in B & S Healt…
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M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.
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[Archived] Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.
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Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).
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Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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Accord Healthcare Limited has informed us that that a change to the Patient Information Leaflet (PIL) for
this product has not been implemented by the required timeline.
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Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.
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Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
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Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
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List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018
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List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018
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Some valsartan containing products including certain batches supplied by Teva UK Limited and all unexpired batches supplied by Mylan are being recalled.
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Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
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Daiichi Sankyo UK Limited has informed us that there is an error on the blister foil of specific batches of Olmetec 20mg Film-Coated Tablets
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FDC International Ltd are recalling specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml due to the presence of a precipitate, which has been identified as Sodium C…
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IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date.
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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)
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Rosemont Pharmaceuticals Limited, MS 427 is issuing a company-led drug alert for an unlicensed medicine Phenytoin 90mg/5ml Oral Suspension (CLDA (18)A/02).