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Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet for specified batches of Entyvio 108mg pre-filled syringes.
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Generics (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Omeprazole 40 mg Powder for solution for infusion do not contain the most up to date safety information.
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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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Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.
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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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Glenmark Pharmaceuticals Europe Ltd is recalling the affected batches as a precautionary measure due to out of specification results for unknown impurities during routine stability testing and additional re-testing.
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Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles within the tablets.
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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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Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Linezolid 600 mg film-coated tablets.
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Generics (UK) Ltd T/A Mylan UK is recalling specific batches of trandolapril after re-testing showed out
of specification results.
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Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Rosuvastatin 20mg and 40mg Tablets.
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Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.
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Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg, 2mg and 3mg and Tablets.
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Orion Pharma (UK) Ltd is recalling this batch as a precautionary measure due to an out of specification result in the assay result during the follow up stability study of the batch.
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Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 a…
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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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Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.
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Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting.
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Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml …
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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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Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results.
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Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification.
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Glenmark Pharmaceuticals Europe Ltd is recalling various batches after retesting showed out of specification results.
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Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.
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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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Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.
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Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.
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Sun Pharma UK Ltd is recalling certain batches as a precautionary measure due to a small number of leaks found intermittently in the infusion bags.
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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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Kent Pharma UK is recalling various batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or …
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Accord Healthcare Ltd is recalling various batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule content…
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PHARMATHEN S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75mg film coated tablets is missing the medicines legal classification for a Prescription Only Medicine ‘POM.’ This notification con…
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Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.
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Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the most up to…
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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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Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testin…
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Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents …
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Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table.
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Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.
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The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification. Doncaster Pharma Limited have identified an err…
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Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.
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A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.
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Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry …
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Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.
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Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into the specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex.
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Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
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medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
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Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in th…
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Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
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Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high related substances test results after their release to the marke…