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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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List of Field Safety Notices from 30 September to 4 October 2024
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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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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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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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.
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List of Field Safety Notices from 23 to 27 September 2024.
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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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List of Field Safety Notices from 16 to 20 September 2024.
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List of Field Safety Notices from 9 to 13 September 2024
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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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List of Field Safety Notices from 2 to 6 September 2024.
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List of Field Safety Notices from 26 to 30 August 2024.
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Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of …
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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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List of Field Safety Notices from 19 to 23 August 2024.
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List of Field Safety Notices from 12 to 16 August 2024.
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Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.
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List of Field Safety Notices from 5 to 9 August 2024.
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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/…
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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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List of Field Safety Notices from 29 July to 2 August 2024.
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Glenmark Pharmaceuticals Europe Ltd is recalling various batches after retesting showed out of specification results.
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List of Field Safety Notices from 22 to 26 July 2024.
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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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List of Field Safety Notices from 15 to 19 July 2024.
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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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List of Field Safety Notices from 8 to 12 July 2024.
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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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List of Field Safety Notices from 1 to 5 July 2024.
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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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List of Field Safety Notices from 24 to 28 June 2024.
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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 particle…
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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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List of Field Safety Notices from 17 to 21 June 2024.
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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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List of Field Safety Notices from 10 to 14 June 2024.
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List of Field Safety Notices from 3 to 7 June 2024.
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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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List of Field Safety Notices from 27 to 31 May 2024.
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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 t…