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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 safet…
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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.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 July to 31 July 2020
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Accord-UK Ltd has informed us of an issue related to decommissioning of a specific batch
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Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential l…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 2020
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Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse react…
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Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.
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Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion so…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 2020
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Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the affected batches below contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instr…
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Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in …
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Ferring Pharmaceuticals Limited is recalling all unexpired stock of the products below from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of sp…
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Dr Reddy’s Laboratories (UK) Limited is recalling all unexpired stock of a specific batch of Nitrofurantoin 50mg Tablets from pharmacies and wholesalers as a precautionary measure due to out of specification results for diss…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 06 July to 10 July 2020
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Manufactured by Synthes GmbH – cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 29 June to 03 July 2020
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Manufactured by Abbott – cases of valvular insufficiency and early revision.
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BCM Specials Limited is recalling a specific batch of Mepacrine Hydroxychloride 100 mg tablets due to a number of foreign body particulates found in the containers of the API used to make it.
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Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.
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Manufactured by Philips – the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 22 June to 26 June 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 2020
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The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 08 to 12 June 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 01 to 05 May 2020
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Torbay Pharmaceuticals is recalling specific batches of Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) due to a potentially faulty and incorrectly engaged child-resistant container closure.
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This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)