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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.
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The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine, and stop supply of any identified p…
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List of Field Safety Notices from 10 to 14 March 2025.
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Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.
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List of Field Safety Notices from 3 to 7 March 2025.
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Aspar Pharmaceuticals Limited have informed the MHRA of an error related to a batch of Boots Paracetamol 500 mg tablets (16s). The foil blister inside the carton incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. The t…
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Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during st…
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List of Field Safety Notices from 24 to 28 February 2025.
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Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compo…
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List of Field Safety Notices from 17 to 21 February 2025.
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All batches of the named products are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the i…
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List of Field Safety Notices from 10 to 14 February 2025.
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List of Field Safety Notices from 3 to 7 February 2025.
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Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro…
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CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule contain…
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List of Field Safety Notices from 27 to 31 January 2025.
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Bristol Laboratories Limited is recalling the batches specified in the table as a precautionary measure due to possible microbial contamination.
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List of Field Safety Notices from 23 to 27 December 2024
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List of Field Safety Notices from 20 to 24 January 2025.
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List of Field Safety Notices from 13 to 17 January 2025.
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Bells Healthcare is recalling the listed batches of dextromethorphan hydrobromide BP containing products as a precautionary measure, due to foreign material detected in some bottles.
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List of Field Safety Notices from 21 to 25 August 2023
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List of Field Safety Notices from 19 to 23 June 2023
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List of Field Safety Notices from 6 to 10 January 2025.
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Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.
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Bristol Laboratories Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the batches in the table for Rabeprazole sodium 10mg and 20mg gastro-resistant tablets do not contain the most up to date safet…
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List of Field Safety Notices from 30 December 2024 to 3 January 2025.
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List of Field Safety Notices from 16 to 20 December 2024.
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List of Field Safety Notice for 20 December 2024.
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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.