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List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 July 2022.
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Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.
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Omega Pharma Limited have identified an error relating to the product packaging.
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hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure.
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Thornton & Ross have identified that the product labelling for some batches of ‘Pharmacy’ medicines do not contain the ‘P’ symbol, due to a packaging error on the bottle.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 July 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 June to 1 July 2022
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Summary List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 June 2022
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A.Vogel Ltd is recalling a specific batch of Pharmacy only medicine due to a small number of packs that were inadvertently supplied to non-pharmacy retail outlets.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2022
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Altan Pharma Limited have identified an error relating to the product packaging. The incorrect concentration of phenylephrine base is provided on the overwrapping bag label.
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PCCA Limited have been made aware of an issue with the appearance of Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 6 to 10 June 2022
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Bristol Laboratories Limited are recalling a batch of this product as a precautionary measure due to low dissolution test results reported during ongoing stability studies.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May to 3 June 2022.
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Napp Pharmaceuticals Limited have identified an error relating to the Braille printed on the cartons. The
Braille message on the Oxycontin 20mg prolonged release tablets incorrectly states strength as 15mg.
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DEMO SA PHARMACEUTICAL INDUSTRY has informed us that the Product Code/GTIN (PC) number found on the above batch is incorrect. The GTIN number that should have been allocated for this batch is 5200040321010.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 May 2022.
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Consilient Health UK Ltd is recalling a specific batch due to limited units from the batch being distributed prior to batch release.
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Orifarm UK have informed us of an error with the Patient Information Leaflet (PIL) packaged within the packs of certain batches. The product name stated in the heading of the PIL has been spelt incorrectly as “lorazolam”, in…
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The MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequ…
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hameln pharma ltd are recalling batches of product additional to the batch recalled on 15 February 2022 (reference EL(22)A/06).
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 May 2022.
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GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
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Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the t…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 May 2022
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Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 May 2022
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Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 April 2022
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Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa…
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Crescent Pharma Limited are recalling a specific batch of Paroxetine 40mg Film Coated Tablets as a precautionary measure.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 April 2022
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Pfizer Limited have informed the MHRA that an outdated version of the Patient Information Leaflet (PIL) has been included in the packaging of the specific batches mentioned in this notification.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 April 2022
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Summary List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 April 2022
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USV UK Limited are recalling specific batches of products as a precautionary measure due to out of specification results for impurities during routine stability testing.
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The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia.
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List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 March 2022.
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Pfizer Ltd are recalling batch number DD4842 as a precautionary measure due to the identification of a nitrosamine above the acceptable limit.
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 March 2022.
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Brancaster Pharma Limited have notified us of an issue relating to the label of the Water for Injections (solvent) packaged in each finished product pack.
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Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 March 2022.
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Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.
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CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.
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Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets.
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List of field safety notices (FSNs) from medical device manufacturers from 28 February to 4 March 2022.
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Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability testing.
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List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 February 2022.