tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: medicines and medical devices2025-04-02T14:01:02+01:00HM Governmenttag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-142025-04-02T14:01:02+01:00Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14Rosemont 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-24-to-28-march-20252025-04-01T11:08:20+01:00Field Safety Notices: 24 to 28 March 2025List of Field Safety Notices from 24 to 28 March 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-utrogestan-vaginal-200-mg-capsules-progesterone-el-25-a-slash-132025-04-01T10:58:54+01:00Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone), EL(25)A/13Uni 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 �tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-sirdupla-25-microgram-slash-250-microgram-per-metered-dose-pressurised-inhalation-suspension-el-25-a-slash-122025-03-31T11:04:37+01:00Class 4 Medicines Defect Notification: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, EL(25)A/12Cross 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. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-17-to-21-march-20252025-03-26T13:44:31+00:00Field Safety Notices: 17 to 21 March 2025List of Field Safety Notices for 17 to 21 March 2025.tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-march-20252025-03-25T14:36:54+00:00MHRA Safety Roundup: March 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/suzhou-surgicare-disposable-hysteroscopy-sheath-recall-due-to-withdrawn-ce-certificate-dsi-slash-2025-slash-0012025-03-19T13:41:31+00:00Suzhou Surgicare disposable Hysteroscopy Sheath� Recall due to withdrawn CE certificate, (DSI/2025/001)The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate.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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-10-to-14-march-20252025-03-19T11:02:47+00:00Field Safety Notices: 10 to 14 March 2025List of Field Safety Notices from 10 to 14 March 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-azithromycin-250-mg-capsules-el-25-a-slash-112025-03-12T15:28:41+00:00UPDATE: Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-3-to-7-march-20252025-03-11T10:59:15+00:00Field Safety Notices: 3 to 7 March 2025List of Field Safety Notices from 3 to 7 March 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-boots-paracetamol-500-mg-tablets-16s-el-25-a-slash-102025-03-04T14:35:01+00:00Class 2 Medicines Recall: Boots Paracetamol 500 mg tablets (16s), EL(25)A/10Aspar 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�tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-sun-pharmaceutical-industries-europe-b-dot-v-pemetrexed-1000mg-slash-100ml-10mg-slash-ml-and-800mg-slash-ml-8mg-slash-ml-infusion-bag-el-25-a-slash-092025-03-04T11:02:39+00:00Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag, EL(25)A/09Sun 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-24-to-28-february-20252025-03-04T10:02:00+00:00Field Safety Notices: 24 to 28 February 2025List of Field Safety Notices from 24 to 28 February 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-azacitidine-100-mg-slash-vial-and-150-mg-slash-vial-powder-for-suspension-for-injection-el-25-a-slash-082025-03-03T11:03:15+00:00Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection, EL(25)A/08Accord 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-17-to-21-february-20252025-02-25T10:18:45+00:00Field Safety Notices: 17 to 21 February 2025List of Field Safety Notices from 17 to 21 February 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-glucophage-sr-500-mg-750mg-and-1000mg-prolonged-release-tablets-el-25-a-slash-072025-02-20T14:00:20+00:00Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets, EL(25)A/07All 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-10th-14th-february-20252025-02-14T17:11:29+00:00Field Safety Notices: 10th - 14th February 2025List of Field Safety Notices from 10th to14th February 2025tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-3-to-7-february-20252025-02-12T10:06:47+00:00Field Safety Notices: 3 to 7 February 2025List of Field Safety Notices from 3 to 7 February 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-lansoprazole-gastro-resistant-hard-capsules-15mg-el-25-a-slash-062025-02-11T11:00:20+00:00Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06Teva 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�tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-nitrofurantoin-cnx-therapeutics-100-mg-prolonged-release-capsules-el-25-a-slash-052025-02-05T10:00:55+00:00Class 2 Medicines Recall: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules, EL(25)A/05CNX 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-27-to-31-january-20252025-02-04T09:53:20+00:00Field Safety Notices: 27 to 31 January 2025List of Field Safety Notices from 27 to 31 January 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-amlodipine-bristol-lab-2-dot-5-mg-tablets-el-25-a-slash-042025-01-30T11:00:10+00:00Class 2 Medicines Recall: Bristol Laboratories Limited, Amlodipine Bristol Lab 2.5 mg Tablets, EL (25)A/04Bristol Laboratories Limited is recalling the batches specified in the table as a precautionary measure due to possible microbial contamination.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-23-to-27-december-20242025-01-29T13:28:24+00:00Field Safety Notices: 23 to 27 December 2024List of Field Safety Notices from 23 to 27 December 2024tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-20-to-24-january-20252025-01-29T13:26:13+00:00Field Safety Notices: 20 to 24 January 2025List of Field Safety Notices from 20 to 24 January 2025.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-13-to-17-january-20252025-01-22T17:21:07+00:00Field Safety Notices: 13 to 17 January 2025List of Field Safety Notices from 13 to 17 January 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-tesco-health-dry-cough-relief-200ml-asda-strong-dry-tickly-cough-200ml-almus-dry-cough-relief-and-bells-dual-action-dry-cough-el-25-a-slash-032025-01-22T13:07:22+00:00UPDATE: Class 2 Medicines Recall: Tesco Health Dry Cough Relief 200ml, Asda Strong Dry Tickly Cough 200ml, Almus Dry Cough Relief & Bells Dual Action Dry Cough, EL(25)A/03Bells Healthcare is recalling the listed batches of dextromethorphan hydrobromide BP containing products as a precautionary measure, due to foreign material detected in some bottles. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-21-to-25-august-20232025-01-16T12:51:33+00:00Field Safety Notices: 21 to 25 August 2023List of Field Safety Notices from 21 to 25 August 2023tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-19-to-23-june-20232025-01-16T12:32:42+00:00Field Safety Notices: 19 to 23 June 2023List of Field Safety Notices from 19 to 23 June 2023tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-6-to-10-january-20252025-01-14T09:16:44+00:00Field Safety Notices: 6 to 10 January 2025List of Field Safety Notices from 6 to 10 January 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-irbesartan-150-mg-and-300-mg-film-coated-tablets-el-25-a-slash-022025-01-13T11:01:21+00:00Class 4 Medicines Notification: Irbesartan 150 mg and 300 mg film-coated tablets, EL(25)A/02Jubilant 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.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-rabeprazole-sodium-10mg-and-20mg-gastro-resistant-tablets-el-25-a-slash-012025-01-09T11:10:43+00:00Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01Bristol 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-30-december-2024-to-3-january-20252025-01-07T09:17:26+00:00Field Safety Notices: 30 December 2024 to 3 January 2025List of Field Safety Notices from 30 December 2024 to 3 January 2025.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-16-to-20-december-20242024-12-24T13:08:30+00:00Field Safety Notices: 16 to 20 December 2024List of Field Safety Notices from 16 to 20 December 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-20-december-20242024-12-20T16:35:23+00:00Field Safety Notices: 20 December 2024List of Field Safety Notice for 20 December 2024.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-argenx-bv-vyvgart-1000-mg-solution-for-injection-el-24-a-slash-632024-12-19T11:06:52+00:00Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63Argenx 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.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-9-to-13-december-20242024-12-17T11:41:03+00:00Field Safety Notices: 9 to 13 December 2024List of Field Safety Notices from 9 to 13 December 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-2-to-6-december-20242024-12-10T09:03:35+00:00Field Safety Notices: 2 to 6 December 2024List of Field Safety Notices from 2 to 6 December 2024.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-limited-wockair-160-microgram-slash-4-dot-5-microgram-inhalation-powder-el-24-a-slash-622024-12-09T11:03:55+00:00Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder, EL(24)A/62Wockhardt 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-25-to-29-november-20242024-12-05T09:41:28+00:00Field Safety Notices: 25 to 29 November 2024List of Field Safety Notices from 25 to 29 November 2024.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-brillpharma-limited-oxybutynin-hydrochloride-brillpharma-2-dot-5-mg-slash-5-ml-oral-solution-el-24-a-slash-612024-12-04T11:01:02+00:00Class 4 Medicines Defect Information: Brillpharma Limited, Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, EL(24)A/61L 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�tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-phenoxymethylpenicillin-250mg-slash-5ml-oral-solution-sugar-free-el-24-a-slash-602024-12-03T14:17:57+00:00Class 3 Medicines Recall: Kent Pharma UK, Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free, EL (24)A/60Kent Pharma UK is recalling a batch of phenoxymethylpenicillin 250mg/5mL oral solution sugar free due to a low phenoxymethylpenicillin assay.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-rosemont-pharmaceuticals-limited-mycophenolate-mofetil-1g-slash-5ml-oral-suspension-el-24-a-slash-592024-12-02T14:00:03+00:00Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Limited, Mycophenolate Mofetil 1g/5ml Oral Suspension, EL(24)A/59Rosemont 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.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-strides-pharma-uk-ltd-liothyronine-sodium-5-and-20-micrograms-tablets-el-24-a-slash-582024-11-28T11:07:36+00:00Class 4 Medicines Defect Information: Strides Pharma UK Ltd, Liothyronine Sodium 5 & 20 micrograms Tablets, EL(24)A/58Strides 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.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-morningside-healthcare-limited-tramadol-hydrochloride-50-mg-capsules-and-tramadol-hydrochloride-morningside-50-mg-prolonged-release-capsules-el-24-a-slash-572024-11-27T13:59:23+00:00Class 4 Medicines Defect Information: Morningside Healthcare Limited, Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, EL(24)A/57Morningside 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�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-18-to-22-november-20242024-11-26T12:22:32+00:00Field Safety Notices: 18 to 22 November 2024List of Field Safety Notices from 18 to 22 November 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-25-november-20242024-11-26T09:46:21+00:00Field Safety Notices: 25 November 2024List of Field Safety Notices for 25 November 2024.tag:www.gov.uk,2005:/drug-device-alerts/class-3-medicines-recall-syri-limited-t-slash-a-syrimed-baclofen-10mg-slash-5ml-oral-solution-el-24-a-slash-562024-11-25T14:01:22+00:00Class 3 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(24)A/56Syri Limited, T/A SyriMed is recalling this batch of product as a precautionary measure due to crystallisation observed over time in the oral solution. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-11-to-15-november-20242024-11-19T17:29:55+00:00Field Safety Notices: 11 to 15 November 2024List of Field Safety Notices from 11 to 15 November 2024.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-1-to-5-july-20242024-11-19T16:23:13+00:00Field Safety Notices: 1 to 5 July 2024List of Field Safety Notices from 1 to 5 July 2024.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-takeda-uk-limited-entyvio-108mg-solution-for-injection-in-pre-filled-syringe-el-24-a-slash-552024-11-18T14:24:41+00:00Class 4 Medicines Defect Information: Takeda UK Limited, Entyvio 108mg solution for injection in pre-filled syringe, EL(24)A/55Takeda 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.