tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: drugs and medical devices2024-03-12T15:12:07ZHM Governmenttag:www.gov.uk,2005:/drug-device-alerts/magec-x-system-nuvasive-specialized-orthopedics-nso-uk-suspension-lifted-dsi-slash-2024-slash-0022024-03-12T15:12:07ZMAGEC X System, NuVasive Specialized Orthopedics (NSO): UK suspension lifted, (DSI/2024/002)The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-sodiofolin-50-mg-slash-ml-solution-for-injection-slash-infusion-folinic-acid-400mg-slash-8ml-vial-el-24-a-slash-082024-03-12T14:02:04ZClass 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml, solution for injection/infusion (folinic acid 400mg/8ml vial), EL(24)A/08medac 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.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-4-to-8-march-20242024-03-11T10:25:42ZField Safety Notices: 4 to 8 March 2024List of Field Safety Notices from 4 to 8 March 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-26-february-to-1-march-20242024-03-07T11:47:49ZField Safety Notices: 26 February to 1 March 2024List of Field Safety Notices from 26 February to 1 March 2024
tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-19-to-23-february-20242024-02-27T15:30:49ZField Safety Notices:19 to 23 February 2024List of Field Safety Notices from 19 to 23 February 2024tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-concerta-xl-18mg-and-36-mg-prolonged-release-tablets-el-24-a-slash-072024-02-26T10:57:51ZClass 4 Medicines Defect Information: Orifarm UK Ltd, Concerta XL 18mg & 36 mg prolonged release tablets, EL (24)A/07Orifarm 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…tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-5-to-9-february-20242024-02-21T14:46:10ZField Safety Notices: 5 to 9 February 2024List of Field Safety Notices from 5 to 9 February 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-12-to-16-february-20242024-02-21T12:22:08ZField Safety Notices:12 to 16 February 2024List of Field Safety Notices from 12 to 16 February 2024tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-novartis-pharmaceuticals-uk-limited-adakveo-10-mg-slash-ml-concentrate-for-solution-for-infusion-el-24-a-slash-062024-02-21T10:56:35ZClass 2 Medicines Recall: Novartis Pharmaceuticals UK Limited, Adakveo 10 mg/ml concentrate for solution for infusion, EL(24)A/06Novartis 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. tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-torrent-pharma-uk-limited-ramipril-1-dot-25mg-tablets-el-24-a-slash-052024-02-14T15:08:53ZClass 3 Medicines Recall: Torrent Pharma (UK) Limited, Ramipril 1.25mg tablets, EL(24)A/05Torrent 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…tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-29-january-to-2-february-20242024-02-08T15:46:36ZField Safety Notices: 29 January to 2 February 2024List of Field Safety Notices from 29 January to 2 February 2024.tag:www.gov.uk,2005:/drug-device-alerts/paclitaxel-coated-devices-pcd-used-in-the-treatment-of-peripheral-arterial-disease-update-to-previous-mhra-guidance-on-use-where-indicated-pcd-can-be-considered-as-a-treatment-option-for-both-critical-limb-ischaemia-cli-and-interm2024-02-05T13:37:23ZPaclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease: update to previous MHRA guidance on use. Where indicated, PCD can be considered as a treatment option for both critical limb ischaemia (CLI) and intermittent claudication (IC) patients. (DSI/2024/001) Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD). tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-exeltis-uk-limited-gepretix-100mg-capsules-el-24-a-slash-042024-02-01T13:13:29ZClass 4 Medicines Defect Information: Exeltis UK Limited, Gepretix 100mg Capsules, EL (24)A/04Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-fsns-from-22-to-26-january-20242024-01-31T16:28:46ZField Safety Notices (FSNs) from 22 to 26 January 2024List of Field Safety Notices (FSNs) from 22 to 26 January 2024.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-cadila-pharmaceuticals-uk-limited-pantoprazole-40-mg-gastro-resistant-tablets-el-24-a-slash-032024-01-30T11:00:18ZClass 4 Medicines Defect Information: Cadila Pharmaceuticals (UK) Limited, Pantoprazole 40 mg Gastro-Resistant Tablets, EL (24)A/03Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Cres…tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-fsns-from-15-to-19-january-20242024-01-22T11:38:05ZField Safety Notices (FSNs) from 15 to 19 January 2024List of Field Safety Notices (FSNs) from 15 to 19 January 2024.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-usv-uk-limited-sugammadex-100-mg-slash-ml-solution-for-injection-2-ml-vial-el-24-a-slash-022024-01-18T10:59:50ZClass 4 Medicines Defect Information: USV UK Limited, Sugammadex 100 mg/ml solution for injection (2 ml vial), EL(24)A/02USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain a low volume of solution; less than the label claim of 2 ml.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-fsns-from-8-to-12-january-20242024-01-16T16:34:31ZField Safety Notices (FSNs) from 8 to 12 January 2024List of Field Safety Notices from 8 to 12 January 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-fsns-from-1-to-5-january-20242024-01-09T14:50:08ZField Safety Notices (FSNs) from 1 to 5 January 2024List of Field Safety Notices from 1 to 5 January 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-fsns-from-25-to-29-december-20232024-01-05T15:14:19ZField Safety Notices (FSNs) from 25 to 29 December 2023List of Field Safety Notices from 25 to 29 December 2023tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-quadrant-pharmaceuticals-ltd-cozaar-100mg-film-coated-tablets-el-24-a-slash-012024-01-04T09:13:18ZClass 4 Medicines Defect Information: Quadrant Pharmaceuticals Ltd, Cozaar 100mg film-coated tablets, EL(24)A/01Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-fsns-from-18-to-22-december-20232023-12-27T10:42:44ZField Safety Notices (FSNs) from 18 to 22 December 2023List of Field Safety Notices from 18 to 22 December 2023tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-fsns-from-11-to-15-december-20232023-12-19T11:03:05ZField Safety Notices (FSNs) from 11 to 15 December 2023List of Field Safety Notices from 11 to 15 December 2023tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-biocon-pharma-uk-ltd-dot-posaconazole-biocon-100mg-gastro-resistant-tablets-el-23-a-slash-442023-12-14T13:00:22ZClass 3 Medicines Recall: Biocon Pharma UK Ltd., Posaconazole Biocon 100mg Gastro-resistant Tablets, EL(23)A/44Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-limited-clobazam-atnahs-5mg-slash-5ml-and-10mg-slash-5ml-oral-suspension-el-23-a-slash-432023-12-13T11:00:29ZClass 4 Medicines Defect Information: Atnahs Pharma UK Limited, Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension, EL(23)A/43Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-4-to-8-december-20232023-12-12T17:30:25ZField Safety Notices: 4 to 8 December 2023Field Safety Notices from 4 to 8 December 2023.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-strandhaven-ltd-t-slash-a-somex-pharma-clarithromycin-250mg-and-500mg-film-coated-tablets-el-23-a-slash-422023-12-07T16:12:31ZClass 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Clarithromycin 250mg and 500mg film-coated tablets, EL (23)A/42Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablet…tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-strandhaven-ltd-t-slash-a-somex-pharma-tramadol-hydrochloride-50mg-capsules-hard-el-23-a-slash-412023-12-07T16:08:44ZClass 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Tramadol Hydrochloride 50mg Capsules, Hard, EL (23)A/41Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Tramadol Hydrochloride 50mg Capsules, Hard.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-27-november-to-1-december-20232023-12-04T16:42:17ZField Safety Notices: 27 November to 1 December 2023Field Safety Notices from 27 November to 1 December 2023tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-teva-uk-ltd-dot-caramet-25-slash-100mg-cr-tablets-el-23-a-slash-402023-12-04T11:01:14ZClass 4 Medicines Notification: Teva UK Ltd., Caramet 25/100mg CR Tablets, EL(23)A/40Teva UK Ltd. has informed the MHRA of a labelling error. This notification provides further advice on the safe use of the product.tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-astrazeneca-uk-ltd-dot-fluenz-tetra-nasal-spray-suspension-el-23-a-slash-392023-11-30T10:13:15ZClass 3 Medicines Recall: AstraZeneca UK Ltd., Fluenz Tetra nasal spray suspension, EL(23)A/39AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further advice on the safe use of the product up to the amended expiry date.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-20-to-24-november-20232023-11-29T11:58:48ZField Safety Notices: 20 to 24 November 2023List of Field Safety Notices (FSNs) from 20 to 24 November 2023tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-valproate-organisations-to-prepare-for-new-regulatory-measures-for-oversight-of-prescribing-to-new-patients-and-existing-female-patients-natpsa-slash-2023-slash-013-slash-mhra2023-11-28T16:31:49ZNational Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA)The MHRA is asking organisations to put a plan in place to implement new regulatory measures for sodium valproate, valproic acid and valproate semisodium (valproate). This follows a comprehensive review of safety data, advic…tag:www.gov.uk,2005:/drug-device-alerts/specific-brands-of-carbomer-eye-gel-recall-of-aacarb-eye-gel-aacomer-eye-gel-and-puroptics-eye-gel-potential-risk-of-infection-dsi-slash-2023-slash-112023-11-24T11:03:47ZSpecific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection, DSI/2023/11Specific batches of carbomer gel are being recalled as a precaution due to possible
microbiological contamination.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-13-to-17-november-20232023-11-22T16:50:32ZField Safety Notices: 13 to 17 November 2023List of Field Safety Notices from 13 to 17 November 2023.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-6-to-10-november-20232023-11-17T09:19:34ZField Safety Notices: 6 to 10 November 2023List of Field Safety Notices from 6 to 10 November 2023.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-30-october-to-3-november-20232023-11-17T09:19:30ZField Safety Notices: 30 October to 3 November 2023List of Field Safety Notices from 30 October to 3 November 2023.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-23-to-27-october-20232023-10-31T16:24:56ZField Safety Notices: 23 to 27 October 2023List of Field Safety Notices from 23 to 27 October 2023.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-16-to-20-october-20232023-10-25T14:07:11ZField Safety Notices: 16 to 20 October 2023List of Field Safety Notices from 16 to 20 October 2023.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-sandoz-limited-zinacef-powder-for-solution-for-injection-or-infusion-vials-all-strengths-including-stock-in-gsk-livery-el-23-a-slash-382023-10-23T12:57:24ZClass 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-9-to-13-october-20232023-10-16T13:57:14ZField Safety Notices: 9 to 13 October 2023List of Field Safety Notices from 9 to 13 October 2023.tag:www.gov.uk,2005:/drug-device-alerts/sterifeed-colostrum-collection-device-and-risk-of-choking-due-to-infant-airway-occlusion-dsi-slash-2023-slash-0102023-10-10T13:00:27ZSteriFeed Colostrum Collection device and risk of choking due to infant airway occlusion, DSI/2023/010The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as the cap, if not removed, can easily get dislodged and become stuck in…tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-2-to-6-october-20232023-10-10T12:00:28ZField Safety Notices: 2 to 6 October 2023List of Field Safety Notices from 2 to 6 October 2023.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-25-to-29-september-20232023-10-02T09:30:36ZField Safety Notices: 25 to 29 September 2023List of Field Safety Notices from 25 to 29 September 2023.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-max-remedies-ltd-max-healthcare-paracetamol-500-mg-capsules-el-23-a-slash-372023-09-27T12:58:41ZClass 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules, EL (23)A/37Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-18-to-22-september-20232023-09-25T10:48:04ZField Safety Notices: 18 to 22 September 2023List of Field Safety Notices from 18 to 22 September 2023.tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-chiesi-ltd-dot-trimbow-87-slash-5-slash-9-mcg-pressurised-inhalation-solution-el-23-a-slash-362023-09-20T12:58:58ZClass 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stab…tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-11-to-15-september-20232023-09-18T10:40:04ZField Safety Notices: 11 to 15 September 2023List of Field Safety Notices from 11 to 15 September 2023.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-4-to-8-september-20232023-09-12T08:13:11ZField Safety Notices: 4 to 8 September 2023List of Field Safety Notices from 4 to 8 September 2023tag:www.gov.uk,2005:/drug-device-alerts/company-led-medicines-recall-sun-pharma-uk-ltd-gemcitabine-10mg-slash-ml-solution-for-infusion-pl-31750-slash-0062-single-dose-infusion-bag-2000mg-slash-200ml-clmr-23-a-slash-062023-09-07T11:02:36ZCompany led medicines recall: Sun Pharma UK Ltd, Gemcitabine 10mg/ml Solution for Infusion PL 31750/0062 (Single dose Infusion bag, 2000mg/200ml), CLMR(23)A/06Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion.