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Action within 48 hours: Glaxo Wellcome UK Ltd is recalling 4 batches of Respontin Nebules due to out of specification results for impurities obtained during routine stability testing (EL (16)A/10)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 1 - 5 August 2016
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B Braun Medical Ltd is recalling the above batch as a precautionary measure because the Company has received isolated reports of patient reactions (fever, shivering) associated with administration of the batch.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 - 29 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18 - 22 July 2016
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A list of all medical device alerts that were archived in July 2016.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 - 15 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 4 - 8 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June - 1 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 20 - 24 June 2016
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Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.
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List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2016
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Caduceus Pharma Ltd., Pemetrexed 25mg/ml Concentrate for solution for Infusion: caution in use after particulates identified in a small number of vials (EL (16)A/09)
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Action within 48 hours: B&S Healthcare are recalling two batches of parallel imported Medikinet XL 20mg modified-release capsules that have been incorrectly repackaged in 30mg cartons. (EL (16)A/08)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 June 2016
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(Santen UK Ltd) Two batches of Ikervis 1 mg/ml eye drops, emulsion (30 single dose containers) (ciclosporin), are being recalled because micro particles of the active ingredient were found in stability test samples (EL(16)A/…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May - 3 June 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 May 2016
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(Special Products Ltd) A batch of Epistatus 10mg in 1ml Oromucosal Solution is being recalled due to the wrong size of neck adaptor in some bottles (EL (16)A/06)
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(Hospira UK Limited) Paclitaxel 6mg/ml concentrate for solution for infusion; 100mg in 16.7ml - risk of the exterior of vials contaminated with Methotrexate (EL (16)A/05)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 May 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 May 2016
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List of field safety notices (FSNs) from medical device manufacturers from 2 May to 6 May 2016
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Sanofi is recalling the A5545 batch of Rifadin because an investigation of out of trend results indicated that it was contaminated with chilled water circulating in the jacket of the reactor during manufacture. (EL(16)A/04)
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List of field safety notices (FSNs) from medical device manufacturers from 25 April to 29 April 2016
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Potentially a rogue blister and carton may be present in a batch of Crestor 5mg Tablets Parallel Imported by BR Lewis Pharmaceuticals Ltd (Originator name Provisacor) – Class 4 Caution in Use. (EL (16)A/03)
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List of field safety notices (FSNs) from medical device manufacturers from 18 April to 22 April 2016
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Sanofi are recalling the listed batches of Taxotere (Docetaxel) Concentrate due to a production fault potentially leading to an increase in the concentration of Docetaxel in the solution.
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List of field safety notices (FSNs) from medical device manufacturers from 11 April to 15 April 2016
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A list of all medical device alerts that were archived in March 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 4 April to 8 April 2016
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List of field safety notices (FSNs) from medical device manufacturers from 28 March to 01 April.
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List of field safety notices (FSNs) from medical device manufacturers from 21 March to 25 March 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 14 March to 18 March 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 7 March to 11 March 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 29 February to 4 March 2016.
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CME has recommended the need for protection of these pumps when exposed to direct sunlight.
In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with…
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AMCo are recalling the listed batches of Maxolon 5mg/ml as the outer carton contains incorrect administration instructions.
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List of field safety notices (FSNs) from medical device manufacturers from 22 February to 26 February 2016
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List of field safety notices (FSNs) from medical device manufacturers from 15 February to 19 February 2016
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List of field safety notices (FSNs) from medical device manufacturers from 8 February to 12 February 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 1 February to 5 February 2016.
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Action within 48 hours: patient, pharmacy and retail level recall of St John's Wort tablets. Testing has shown the presence of a toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herba…
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List of field safety notices (FSNs) from medical device manufacturers from 25 January to 29 January 2016.
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Precautionary recall because a glass particle has been identified in one syringe from this batch.
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List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 4 January to 8 January 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 28 December to 1 January 2016.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 December 2015