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Summary List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 September 2022
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Novartis Pharmaceuticals UK are recalling a batch of Sandimmun Oral Solution due to the presence of crystals in the solution.
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Rosemont Pharmaceuticals Ltd. has made the MHRA aware that the expiry dates stamped on the base of the bottle are incorrect for 2 batches of Atorvastatin 4mg/ml Oral Suspension and 2 batches of Sildenafil 10mg/ml Oral Suspen鈥�
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Summary List of field safety notices (FSNs) from medical device manufacturers from 5 to 9 September 2022
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Quadrant Pharmaceuticals Limited have informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packaged in various parallel imported batches.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 2 September 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 August 2022
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Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 August 2022.
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The UK Marketing Authorisation Holder has confirmed that a batch of Dysport 500 Units Powder for Solution for Injection is falsified and has been supplied by unauthorised distributors to the UK.
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Accord Healthcare have informed us of an error with the patient information leaflets (PILs) that have been packaged in some Rosuvastatin products.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 August 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 October 2021
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Sun Pharmaceuticals are recalling batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 1 to 5 August 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 July 2022.
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Stockport Pharmaceuticals are recalling a batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (January 2022).
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Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 July 2022.
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Philips Health Systems have identified an important safety issue due to potential unexpected shutdowns of all of their V60 and V60 Plus non-invasive ventilators. All V680 invasive ventilators used in critical care settings 鈥�
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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 鈥楶harmacy鈥� medicines do not contain the 鈥楶鈥� 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 鈥渓orazolam鈥�, in鈥�
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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鈥�
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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鈥�
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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鈥�