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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)
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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 to 29 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 2020
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Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1…
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As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies. An evaluation of the foil laminate pouch identified oxygen le…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 2020
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 4 to 8 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 2020
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GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister…
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TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the below batches is incorrect.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 6 to 9 April 2020
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All manufacturers – there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.
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All anaesthesia machines with ventilators - using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability.
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 300 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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Summary list of field safety notices (FSNs) from medical device manufacturers from 30 March to 3 April 2020
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Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market during a review by MHRA.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 2020
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Rosemont Pharmaceuticals Ltd has informed us of an error in the barcode and GTIN number of the label on the bottle of the below batches.
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Mylan UK Healthcare Ltd has informed us that the GTIN barcode applied on the below batches is incorrect.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 2020
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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 WDA(H) 50340 HMS Wholesale Limited. This License has now been terminated…
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Manufactured by NuVasive Inc. – risk of end cap separation after implantation.
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Gedeon Richter (UK) Ltd is recalling all unexpired stock of Esmya 5 mg tablets from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 March 2020
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Mylan UK Healthcare Ltd has informed us that a product complaint has been received relating to crystalline precipitate being observed during bottle use. Due to concerns with continuity of supply these batches are not being r…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 March 2020
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Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 150 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 24 to 28 February 2020
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AOP Orphan Pharmaceuticals AG is recalling all unexpired stock of a batch of Tetrabenazine 25 mg tablets (from pharmacies and wholesalers) as a precautionary measure due to out of specification results for the assay, obtaine…
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Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.
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Manufactured by Olympus Medical Systems Corp – instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.
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G.L Pharma GmbH T/A Healthcare Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the specified batches is missing important safety relevant text changes.
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Manufactured by CME (a BD company) – updated advice to address ‘wear and tear’ of the syringe pump motor block which may lead to under-infusion.
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Crescent Pharma Ltd has informed us of a discrepancy on the product packaging.
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Crescent Pharma Ltd and Flamingo Pharma (UK) Ltd have informed us that the Patient Information Leaflet (PIL) within their packs for the above pharmacy (P) batches is incorrect.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 February 2020
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Summary List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 February 2020
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Accord Healthcare Ltd has informed us of an issue related to the expiry date for the above batches, which has not been encoded in 2D data matrix.
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Accord-UK Limited is recalling all unexpired stock of Gliclazide 40 mg Tablets (Northstar Livery) from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution, obtained durin…
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Glaxo Wellcome UK Ltd T/A GSK has informed us of an issue related to error in the decommissioning of the K84X batch.
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Accord Healthcare Ltd has informed us that the Patient Information Leaflet (PIL) for all strengths of Atrolak XL Prolonged-release tablets is missing the side effects identified from post-marketing experience.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 February 2020
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Glenmark Pharmaceuticals is recalling specific batches as a precautionary measure.
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List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 2020.
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Medreich Plc is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic …
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Wockhardt UK Ltd is recalling specific batches of Levothyroxine 100micrograms/5ml Oral Solution from pharmacies and wholesalers as a precautionary measure due to notification of the impurity liothyronine exceeding the specif…