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Omega Pharma Limited have identified an error relating to the product packaging.
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Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.
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Strides Pharma UK Ltd has informed MHRA of an error in the patient information leaflet (PIL) for Liothyronine Sodium 20 micrograms Tablets and Liothyronine Sodium 5 micrograms Tablets.
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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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Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.
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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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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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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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The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.
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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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(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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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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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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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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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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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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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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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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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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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 to 29 December 2017
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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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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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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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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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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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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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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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(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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Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches.
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Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
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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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(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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Antibiotice SA have identified an error on PIL of the above batches regarding the sodium content.
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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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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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Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 April 2018
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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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Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.
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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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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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Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons.
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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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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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Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches.
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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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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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Teva UK Ltd. has informed the MHRA of a labelling error. This notification provides further advice on the safe use of the product.