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CD Pharma Ltd have notified the MHRA of an error on the outer carton of the product for the batches listed in this notification. While the total active content statement is correct, the delivered dose content statement is in…
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The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic…
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List of Field Safety Notices from 14 to 18 July 2025.
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List of Field Safety Notices from 7 to 11 July 2025.
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List of Field Safety Notices from 30 June to 4 July 2025.
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Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contaminati…
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Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of simvastatin 10 mg Tablets distributed by Alliance Healthcare UK.
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List of Field Safety Notices from 23 to 27 June 2025.
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Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe b…
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Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.
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Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing.
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Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of th…
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A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentr…
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Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specificatio…
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List of Field Safety Notices from 16 to 20 June 2025.
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Summary of the latest safety advice for medicines and medical device users
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List of Field Safety Notices from 9 to 13 June 2025
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Summary of the latest safety advice for medicines and medical device users
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Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.
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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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List of Field Safety Notices from 2 to 6 June 2025.
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Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of discoloured tablets within the pots.
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List of Field Safety Notices from 19 to 23 May 2025.
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List of Field Safety Notices from 26 to 30 May 2025.
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Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets.
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Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential los…
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Aspen Pharma Trading Limited is recalling a specific batch of Mercaptopurine 50mg tablets as a precautionary measure due to microbial contamination following a small number of complaints of discoloured tablets within the pac…
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List of Field Safety Notices from 12 to 16 May 2025.
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Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This defect could increase the risk of the applicator device being contaminated with pathogens, which cou…
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List of Field Safety Notices from 5 to 9 May 2025.
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Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing…
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List of Field Safety Notices from 28 October to 1 November 2024
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Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the below table.
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List of Field Safety Notices from 28 April to 2 May 2025.
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Summary of the latest safety advice for medicines and medical device users
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List of Field Safety Notices from 21 to 25 April 2025.
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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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List of Field Safety Notices from 14 to 18 April 2025.
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G Pharma Ltd have informed the MHRA that there is an error in the spelling of the active ingredient included on the imported carton. The spelling should be ‘Ticagrelor’ but has been printed as ‘Tricagelor’ under the brand na…
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Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Table…
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List of Field Safety Notices from 7 to 11 April 2025
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Summary of the latest safety advice for medicines and medical device users
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It has been identified that the batches of Synalar Gel 30g and 60g listed in this notification contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. Reig Jofre UK are recalling the batches as a pre…
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List of Field Safety Notices from 31 March to 4 April 2025.
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RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000, which has always been included in Renacet Tablets but has been omitted …
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Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being sta…
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List of Field Safety Notices from 24 to 28 March 2025.
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Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should …
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Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.
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List of Field Safety Notices for 17 to 21 March 2025.