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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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LTC Healthcare has informed the MHRA that they have been selling a medicinal product containing lidocaine without authorisation from the MHRA.
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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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List of Field Safety Notices from 4 to 8 November 2024.
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List of Field Safety Notices for 8 November 2024.
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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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List of Field Safety Notices for 6 November 2024.
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List of Field Safety Notices from 28 October to 1 November 2024
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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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List of Field Safety Notices for 30th October 2024
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List of Field Safety Notices from 21 to 25 October 2024.
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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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List of Field Safety Notices from 14 to 18 October 2024.
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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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List of Field Safety Notices for 18 October 2024.
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List of Field Safety Notices (FSNs) from 7 to 11 October 2024
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List of Field Safety Notices from 7 October to 14 October 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 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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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 a sim…
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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/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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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.