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List of field safety notices (FSNs) from medical device manufacturers from 14 December to 18 December 2020
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Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a…
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Merck Sharp & Dohme Limited is recalling specific batches of Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion as a precautionary measure due to the presence of Ralstonia pickettii in recent batches m…
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Fairmed Healthcare GmbH has informed us of a discrepancy on the product packaging for some batches. The discrepancy relates to the incorrect spelling of one of the active pharmaceutical ingredients printed on one side of the…
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List of field safety notices (FSNs) from medical device manufacturers from 07 December to 11 December 2020
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Generics [UK] Limited t/a Mylan have informed us that the Patient Information Leaflet (PIL) within the packs for the products listed above is missing relevant important safety information.
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List of field safety notices (FSNs) from medical device manufacturers from 30 November to 4 December 2020.
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Lupin Healthcare (UK) Limited has informed us that the affected batches of Simvastatin tablets have been packaged with a version of patient information leaflet that does not include the most up to date safety information.
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List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 November 2020.
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Sanofi is recalling specific batches of Largactil 50mg/2ml Solution for Injection as a precautionary measure due to out of specification results obtained for the impurity chlorpromazine sulphoxide
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Kent Pharmaceuticals Ltd has informed us that several batches of finished product were contaminated with theophylline due to a cross-contamination issue identified with an excipient that was used in the manufacture of the fi…
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Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of double tablets in a single blister pocket.
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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2020.
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List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 November 2020.
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Mylan UK Healthcare Ltd is recalling remaining stock of certain batches as a precautionary measure after a product sterility non-compliance event which occurred during a recent inspection at the contract manufacturing site.
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medac Pharma LLP is recalling a specific batch of products due to some inspected vials showing hairline damage to the shoulder of the vials.
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List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 November 2020.
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Intrapharm Laboratories Ltd has informed us that there is a difference in dosage instructions between the carton and label. The Patient Information Leaflet (PIL) and bottle label contain the correct instructions.
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Regular safety information for healthcare professionals
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List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2020.
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Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us of an issue related to error in the decommissioning of a further batch. Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the stat…
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List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2020.
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Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of…
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List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 2020.
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This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices. It is aimed at all parts of the hea…
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Accord Healthcare Ltd has informed us that when decommissioning at the pharmacy and scanning the serialised 2D code, the status of certain packs may report as ‘EXPORT.’
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Sanofi is recalling batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 5 October to 9 October 2020
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The Boots Company PLC is recalling a specific batch of Hydrocortisone 1% w/w Ointment as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa.
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List of field safety notices (FSNs) from medical device manufacturers from 28 September to 02 October 2020
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Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us that when decommissioning at the pharmacy and when scanning the serialised 2D code, the status of certain packs of AlfaD capsules may report as ‘EXPORT’
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 26 September 2020
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List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 August 2019.
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Actions to be taken to avoid potential unexpected shutdown leading to complete loss of ventilation
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List of Field Safety Notices (FSNs) from medical device manufacturers from 14 September to 18 September 2020
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Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown
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Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2020.
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Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important …
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Summary list of field safety notices (FSNs) from medical device manufacturers from 1 to 4 September 2020.
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Accord Healthcare Limited is recalling a specific batch of Amlodipine 10mg Tablets as a precautionary measure due to out of specification results obtained during stability testing.
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The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that do…
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GL Pharma is recalling a specific batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution during routine stability testing.
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Based on MHRA’s review of available data, the Commission on Human Medicines’ Paediatric Medicine Expert Advisory Group (PMEAG) has advised that Wockhardt UK’s Amoxicillin Sodium Powder for Solution for Injection can be used …
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Summary list of field safety notices (FSNs) from medical device manufacturers from 17 August to 21 August 2020.
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Sanofi is recalling batch number A9306 of the above product as a precautionary measure due to an out of specification result detected for Rasburicase enzyme activity according to a specific method and specifications for US m…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 10 August to 14 August 2020.
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Fresenius Kabi Ltd & Calea UK Ltd has informed us of an error on the bag labels for SmofKabiven extra nitrogen electrolyte free, emulsion for infusion PL 08828/0269.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 31 July to 07 August 2020.
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Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X. The decision to recall all other batches has been made as a precau…
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Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe.