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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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List of Field Safety Notices from 9 to 13 December 2024.
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List of Field Safety Notices from 2 to 6 December 2024.
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Wockhardt UK Limited is recalling this batch as a precautionary measure following the identification of a low number of units which may have a defect in the 'top case' resulting in a dose not being able to be dispens…
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List of Field Safety Notices from 25 to 29 November 2024.
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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(PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, da…
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Kent Pharma UK is recalling a batch of phenoxymethylpenicillin 250mg/5mL oral solution sugar free due to a low phenoxymethylpenicillin assay.
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Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw a dose.
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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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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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List of Field Safety Notices from 18 to 22 November 2024.
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List of Field Safety Notices for 25 November 2024.
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Syri Limited, T/A SyriMed is recalling this batch of product as a precautionary measure due to crystallisation observed over time in the oral solution.
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List of Field Safety Notices from 11 to 15 November 2024.
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List of Field Safety Notices from 1 to 5 July 2024.
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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, …