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Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap.
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Error relating to the wording on the outer carton label for Mometasone Furoate 50 Microgram / Dose Nasal Spray, supplied by PilsCo Ltd.
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List of Field Safety Notices from 25 to 29 August 2025.
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(Pfizer Limited) Very small number of ampoules containing glass particles identified – class 3 action within 5 days. (EL (13)A/14)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 to 29 December 2017
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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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Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.
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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution (>…
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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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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…
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An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem compone…
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Galderma UK identified an error regarding an older version of artwork being used and packed with specific batches of Tetralysal 300mg Hard Capsules.
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Napp Pharmaceuticals Limited have noticed and an error in the PIL of specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets.
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(Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the UK including an investigation into a fatality. (MDA/2007/078)
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Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro…
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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification.
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Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.
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Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
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Morningside Healthcare Limited has informed the MHRA of a packaging issue identified in batch MRA2303 of Tramadol Hydrochloride Morningside 50 mg Prolonged-Release Capsules and batch MRF2301 of Tramadol Hydrochloride 50 mg C…
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Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.
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Jubilant Pharmaceuticals BV has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine ‘POM’. There…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 2017.
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L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, da…
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Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, …
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Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Cres…
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(Aventis Pharma Limited and Winthrop Pharmaceuticals UK Limited) The smell associated with some batches is said to be a result of the foil packaging, but patients should continue taking their medicine. (EL (15)A/02)
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Summary List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 August 2017
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Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.
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Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 April 2018
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Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.
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Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the below batches of products.
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List of Field Safety Notices from 13 to 17 January 2025.
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Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).
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Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures …
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ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).
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Reckitt Benckiser Healthcare (UK) Limited has informed the MHRA that a typographical error has been identified on the end flap of the outer carton of some batches of Lemsip Max Cold & Flu Capsules.
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Teva UK Ltd. has informed the MHRA of a labelling error. This notification provides further advice on the safe use of the product.
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Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.
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Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm i…
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Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.
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A list of all medical device alerts that were archived in May 2015.
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(GlaxoSmithKline) Check each vial for cracks by turning upside down and looking for chips, cracks or damage where base meets side wall. (EL (14)A/15)
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Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-…
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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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Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and …
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Galderma (U.K.) Limited has informed the MHRA that the patient information leaflet (PIL) packaged in specific batches of Etrivex Shampoo is missing safety information
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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.