tag:www.gov.uk,2005:/drug-device-alertsAlerts, recalls and safety information: medicines and medical devices2025-06-13T15:11:47+01:00HM Governmenttag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-may-20252025-06-13T15:11:47+01:00MHRA Safety Roundup: May 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-inhixa-12000iu-120mg-slash-0-dot-8ml-solution-for-injection-maxearn-limited-el-25-a-slash-272025-06-12T14:40:15+01:00Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton. tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-dulcolax-adult-5-mg-gastro-resistant-tablets-opella-healthcare-uk-el-25-a-slash-262025-06-10T10:59:22+01:00Class 4 Medicines Defect Notification: Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare UK, EL(25)A/26Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). 皇冠体育app dose instruction incorrectly states for use in 12 years and 鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-2-to-6-june-20252025-06-10T10:23:25+01:00Field Safety Notices: 2 to 6 June 2025List of Field Safety Notices from 2 to 6 June 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-paracetamol-500mg-tablets-chelonia-healthcare-limited-el-25-a-slash-252025-06-09T11:01:59+01:00Class 2 Medicines Recall: Paracetamol 500mg Tablets, Chelonia Healthcare Limited, EL(25)A/25Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of discoloured tablets within the pots.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-19-to-23-may-20252025-06-06T13:18:06+01:00Field Safety Notices: 19 to 23 May 2025List of Field Safety Notices from 19 to 23 May 2025.tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-26-to-30-may-20252025-06-03T10:26:52+01:00Field Safety Notices: 26 to 30 May 2025List of Field Safety Notices from 26 to 30 May 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-zentiva-pharma-uk-limited-various-products-el-25-a-slash-242025-06-02T11:01:44+01:00Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets.tag:www.gov.uk,2005:/drug-device-alerts/philips-respironics-bipap-a-series-ventilators-alarm-malfunction-and-risk-of-therapy-interruptions-in-ventilators-not-intended-for-life-support-dsi-slash-2024-slash-0062025-05-23T14:47:57+01:00Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006Philips 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鈥�tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-mercaptopurine-50mg-tablets-aspen-pharma-trading-limited-el-25-a-slash-232025-05-22T10:00:25+01:00Class 2 Medicines Recall: Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited, EL (25)A/23Aspen Pharma Trading Limited is recalling a specific batch of Mercaptopurine 50mg tablets as a precautionary measure due to microbial contamination following a small number of complaints of discoloured tablets within the pac鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-12-to-16-may-20252025-05-20T09:10:50+01:00Field Safety Notices: 12 to 16 May 2025List of Field Safety Notices from 12 to 16 May 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bd-chloraprep-clear-1ml-applicator-becton-dickinson-uk-ltd-el-25-a-slash-222025-05-19T14:06:38+01:00Class 2 Medicines Recall: BD ChloraPrep Clear - 1mL Applicator, Becton Dickinson UK Ltd, EL(25)A/22Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This defect could increase the risk of the applicator device being contaminated with pathogens, which cou鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-5-to-8-may-20252025-05-14T08:47:13+01:00Field Safety Notices: 5 to 9 May 2025List of Field Safety Notices from 5 to 9 May 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-chemidex-pharma-ltd-various-products-el-25-a-slash-212025-05-13T11:00:04+01:00Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-28-october-to-1-november-20242025-05-08T16:57:00+01:00Field Safety Notices: 28 October to 1 November 2024List of Field Safety Notices from 28 October to 1 November 2024tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-chloramphenicol-1-percent-w-slash-w-eye-ointment-blumont-pharma-limited-el-25-a-slash-202025-05-08T13:59:42+01:00Class 4 Medicines Defect Notification: Chloramphenicol 1% w/w Eye Ointment, Blumont Pharma Limited, EL(25)A/20Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the below table. tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-28-april-to-2-may-20252025-05-06T09:41:00+01:00Field Safety Notices: 28 April to 2 May 2025List of Field Safety Notices from 28 April to 2 May 2025.tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-april-20252025-04-29T13:59:27+01:00MHRA Safety Roundup: April 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-21-to-25-april-20252025-04-29T12:02:02+01:00Field Safety Notices: 21 to 25 April 2025List of Field Safety Notices from 21 to 25 April 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-pregabalin-25mg-50mg-75mg-100mg-150mg-200mg-225mg-300mg-capsules-jubilant-pharmaceuticals-nv-el-25-a-slash-192025-04-29T11:01:44+01:00Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV, EL(25)A/19Jubilant Pharmaceuticals BV has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine 鈥楶OM鈥�. 皇冠体育appre鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-14-to-18-april-20252025-04-25T09:35:42+01:00Field Safety Notices: 14 to 18 April 2025List of Field Safety Notices from 14 to 18 April 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-brilique-90mg-tablets-el-25-a-slash-182025-04-24T11:01:57+01:00Class 4 Medicines Defect Notification: Brilique 90mg Tablets, EL(25)A/18G Pharma Ltd have informed the MHRA that there is an error in the spelling of the active ingredient included on the imported carton. 皇冠体育app spelling should be 鈥楾icagrelor鈥� but has been printed as 鈥楾ricagelor鈥� under the brand na鈥�tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-lercanidipine-hcl-20mg-tablets-recordati-industria-el-25-a-slash-172025-04-17T13:46:18+01:00Class 2 Medicines Recall: Lercanidipine HCl 20mg Tablets, Recordati Industria, EL(25)A/17Recordati 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. 皇冠体育app error is limited to one batch of Lercanidipine HCl 20mg Table鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-7-to-11-april-20252025-04-15T14:38:51+01:00Field Safety Notices: 7 to 11 April 2025List of Field Safety Notices from 7 to 11 April 2025tag:www.gov.uk,2005:/drug-device-alerts/mhra-safety-roundup-march-20252025-04-08T17:53:02+01:00MHRA Safety Roundup: March 2025Summary of the latest safety advice for medicines and medical device userstag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-synalar-gel-30g-synalar-gel-60g-fluocinoline-acetonide-0-dot-025-percent-reig-jofre-uk-el-25-a-slash-162025-04-08T12:58:22+01:00Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig Jofre UK,EL(25)A/16It 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鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-31-march-to-4-april-20252025-04-08T08:49:18+01:00Field Safety Notices: 31 March to 4 April 2025List of Field Safety Notices from 31 March to 4 April 2025.tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-notification-renacet-475-mg-and-950-mg-tablets-calcium-acetate-renacare-nephromed-gmbh-el-25-a152025-04-07T14:23:59+01:00Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL(25)A15RenaCare 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 鈥�tag: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. 皇冠体育app recall is due to errors in some of the dose calculation in millilitres being sta鈥�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. 皇冠体育app carton label references 鈥榤icrograms鈥� where it should 鈥�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/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鈥� Recall due to withdrawn CE certificate, (DSI/2025/001)皇冠体育app 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鈥�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). 皇冠体育app foil blister inside the carton incorrectly states 鈥楢spirin 300 mg Dispersible Tablets鈥�. 皇冠体育app t鈥�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鈥�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鈥�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鈥�tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-10th-14th-february-20252025-02-14T17:11:29+00:00Field Safety Notices: 10 to 14 February 2025List of Field Safety Notices from 10 to 14 February 2025.tag: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. 皇冠体育appre are two instances where the dosage form is stated as 鈥渢ablets鈥� where it should state 鈥済astro鈥�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 皇冠体育apprapeutics 100 mg Prolonged-Release capsules, EL(25)A/05CNX 皇冠体育apprapeutics 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. 皇冠体育app registered product is a capsule contain鈥�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 2024