tag:www.gov.uk,2005:/drug-device-alerts 2024-12-19T11:06:52+00:00 HM Government tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-notification-argenx-bv-vyvgart-1000-mg-solution-for-injection-el-24-a-slash-63 2024-12-19T11:06:52+00:00

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.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-pfizer-limited-oxbryta-500mg-tablets-voxelotor-el-24-a-slash-44 2024-09-30T13:15:15+01:00

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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-glaxo-wellcome-uk-limited-trading-as-glaxosmithkline-uk-flolan-1-dot-5-mg-powder-and-solvent-for-solution-for-infusion-el-24-a-slash-30 2024-07-22T15:01:01+01:00

Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-desitin-pharma-uk-ltd-lamotrigine-desitin-10mg-slash-ml-oral-suspension-el-24-a-slash-20 2024-06-06T13:59:27+01:00

Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testin�

tag:www.gov.uk,2005:/drug-device-alerts/0-dot-9-percent-sodium-chloride-solutions-for-irrigation-inhalation-and-eyewash-recall-from-manufacturer-legency-remedies-dsi-slash-2024-slash-004 2024-04-04T14:02:30+01:00

Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.

tag: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-06 2024-02-21T10:56:35+00:00

Novartis 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/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-11 2023-11-24T11:03:47+00:00

Specific batches of carbomer gel are being recalled as a precaution due to possible microbiological contamination.

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-medical-beds-trolleys-bed-rails-bed-grab-handles-and-lateral-turning-devices-risk-of-death-from-entrapment-or-falls-natpsa-slash-2023-slash-010-slash-mhra 2023-08-30T14:30:55+01:00

The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.

tag:www.gov.uk,2005:/drug-device-alerts/ethypharm-aurum-pre-filled-syringes-are-incompatible-with-some-manufactured-needle-free-connectors-risk-of-delay-in-administering-potentially-lifesaving-medication-dsi-slash-2023-slash-008 2023-08-22T11:51:33+01:00

Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille�

tag:www.gov.uk,2005:/drug-device-alerts/eyecee-one-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-update-of-previous-quarantine-advice-after-identification-of-likely-cause-dsi-slash-2023-slash-007 2023-08-03T13:57:50+01:00

The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-b-braun-medical-ltd-various-products-el-23-a-slash-27 2023-07-31T12:55:32+01:00

B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-buccolam-10mg-oromucosal-solution-el-23-a-slash-18 2023-05-22T14:00:14+01:00

Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-emerade-500-micrograms-and-emerade-300-micrograms-auto-injectors-due-to-the-potential-for-device-failure-natpsa-slash-2023-slash-004-slash-mhra 2023-05-09T12:30:14+01:00

Pharmaswiss ÄŚeska republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-pholcodine-containing-products-el-23-a-slash-09 2023-03-14T11:01:17+00:00

Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-nidek-eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-risk-of-increased-intraocular-pressure-natpsa-slash-2023-slash-003-slash-mhra 2023-02-01T15:29:50+00:00

The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distribute�

tag:www.gov.uk,2005:/drug-device-alerts/eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-stop-using-immediately-and-quarantine-all-preloaded-eyecee-one-lenses-dsi-slash-2023-slash-001 2023-01-26T09:10:36+00:00

The MHRA is aware of reports of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs).

tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notices-21-to-25-november-2022 2022-11-28T15:34:54+00:00

List of Field Safety Notices (FSNs) from 21 to 25 November 2022

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-4-medicines-defect-information-prenoxad-1mg-slash-ml-solution-for-injection-macarthys-laboratories-aurum-pharmaceuticals-ltd-slash-ethypharm-group-due-to-potential-missing-needles-in-sealed-kits 2022-11-10T13:00:37+00:00

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-targocid-200mg-powder-for-solution-for-injection-slash-infusion-or-oral-solution-aventis-pharma-limited-t-slash-a-sanofi-due-to-the-presence-of-bacteria 2022-10-21T11:00:35+01:00

Sanofi UK is initiating an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-hikma-pharmaceuticals-usa-inc-lorazepam-2mg-slash-ml-injection-lorazepam-4mg-slash-ml-injection-unlicensed-medicines 2022-08-30T11:00:10+01:00

Hikma Pharmaceuticals USA Inc are recalling the below batches due to an out of specification result with related substances during testing for retain samples.

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-mexiletine-hydrochloride-50mg-100mg-and-200-mg-hard-capsules-clinigen-healthcare-ltd-due-to-a-potential-for-underdosing-and-slash-or-overdosing-natpsa-s 2022-08-04T14:28:26+01:00

Clinigen Healthcare Ltd is initiating a recall of three batches of Mexiletine hydrochloride hard capsules due to a potential risk of underdose or overdose, which could have consequences for the safety of patients.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-fresenius-kabi-limited-sodium-bicarbonate-1-dot-26-percent-solution-for-infusion-el-22-a-slash-20 2022-04-28T13:00:27+01:00

Fresenius Kabi Limited are recalling a specific batch of product as a precautionary measure due to the identification of particles in the solution for injection, following routine batch analysis and subsequent batches manufa�

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-34 2021-12-01T16:55:42+00:00

Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.

tag:www.gov.uk,2005:/drug-device-alerts/handpieces-used-in-the-phacoemulsification-technique-of-cataract-removal-need-for-careful-cleaning-dsi-slash-2021-slash-009 2021-11-24T09:51:01+00:00

Residue particles can end up in the patient’s eye. For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-vygoris-limited-mitocin-mitomycin-20mg-powder-for-solution-for-injection-slash-infusion-or-intravesical-use-el-21-a-slash-27 2021-11-08T11:34:13+00:00

Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution (&gt�

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-rosemont-pharmaceuticals-limited-metformin-hydrochloride-500mg-slash-5ml-oral-solution-pl-00427-slash-0139-el-21-a-slash-20 2021-08-25T13:00:19+01:00

Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-19 2021-08-09T11:00:31+01:00

Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-kyowa-kirin-limited-xomolix-2-dot-5-mg-slash-ml-solution-for-injection-el-21-a-slash-15 2021-07-01T11:00:57+01:00

Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-brown-and-burk-uk-ltd-teva-uk-ltd-irbesartan-containing-and-losartan-containing-products-el-21-a-slash-14 2021-06-17T10:00:43+01:00

Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity.

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-co-codamol-30-slash-500-effervescent-tablets-batch-1k10121-zentiva-pharma-uk-ltd-due-to-precautionary-risk-of-causing-overdose-natpsa-slash-2021-slash-0 2021-06-16T11:00:08+01:00

Zentiva Pharma UK Limited is recalling the above batch of Co-codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for �

tag:www.gov.uk,2005:/drug-device-alerts/national-patient-safety-alert-supply-disruption-of-sterile-infusion-sets-and-connectors-manufactured-by-becton-dickinson-bd-natpsa-slash-2021-slash-001-slash-mhra 2021-03-11T16:33:47+00:00

BD have notified the MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-eaststone-limited-midabuc-midazolam-as-hcl-10mg-slash-ml-oromucosal-solution-el-21-a-slash-04 2021-02-16T10:00:09+00:00

Eaststone Limited has informed us of an issue related to underfilled or empty bottles for MidaBuc - Midazolam (as HCL) 10mg/mL Oromucosal Solution. The below batch is being recalled.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-medicines-defect-information-ambisome-liposomal-50-mg-powder-for-dispersion-for-infusion-pl-16807-slash-0001-el-21-a-slash-03 2021-02-11T12:30:38+00:00

Gilead Sciences Ltd has informed us of a quality defect issue, in relation to specific lots of 5µm sterile filters, which are co-packed in cartons of the AmBisome product. The medical device is called Minisart Filter 16534-�

tag:www.gov.uk,2005:/drug-device-alerts/company-led-drug-alert-optiray-300mg-i-ml-solution-for-injection-or-infusion-pl-12308-0028-and-optiray-350mg-i-ml-solution-for-injection-or-infusion-pl-12308-0032 2020-10-22T15:00:29+01:00

Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of�

tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-xl-defibrillator-monitor-therapy-selector-switch-may-fail-mda-2020-018 2020-06-30T10:00:03+01:00

Manufactured by Philips � the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.

tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-mrx-monitor-defibrillators-may-fail-to-deliver-therapy-without-alerting-the-user-to-a-fault-in-the-event-of-internal-damage-mda-2020-016 2020-06-17T14:01:13+01:00

The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

tag:www.gov.uk,2005:/drug-device-alerts/tympanic-thermometers-revision-of-the-calibration-frequency-of-cardinal-health-genius-2-and-genius-3-models 2020-02-27T14:00:37+00:00

Manufactured by Cardinal Health � calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.

tag:www.gov.uk,2005:/drug-device-alerts/professional-use-defibrillator-monitor-efficia-dfm100-model-number-866199-risk-of-failure-to-switch-on-or-unexpected-restart 2019-10-31T12:00:05+00:00

Manufactured by Philips � due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.

tag:www.gov.uk,2005:/drug-device-alerts/intraoperative-probe-cover-with-long-surgi-tip-risk-of-infection-due-to-manufacturing-failure-specific-lot-numbers-affected-mda-2019-034 2019-10-09T11:00:18+01:00

Manufactured by Ecolab/Microtek Medical Malta Ltd � bacterial contamination may cause an infection in patients.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-zantac-injection-50mg-2ml-zantac-syrup-150mg-10ml-zantac-tablets-150mg-zantac-tablets-300mg-el-19-a-24 2019-10-08T15:32:28+01:00

GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.

tag:www.gov.uk,2005:/drug-device-alerts/automated-external-defibrillators-all-telefunken-hr1-fa1-no-valid-ce-certificate-mda-2019-027 2019-07-25T14:05:29+01:00

Manufactured by Defiteq International BV or GGT Holding BV � the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

tag:www.gov.uk,2005:/drug-device-alerts/pagewriter-cardiographs-tc20-30-50-70-manufactured-before-20-november-2018-and-efficia-monitors-cm10-12-100-120-150-manufactured-before-25-october-2018-risk-of-batteries-overheating-or-igniting-mda-2019-017 2019-03-20T11:00:25+00:00

Manufactured by Philips � this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.

tag:www.gov.uk,2005:/drug-device-alerts/class-4-defect-information-atropine-sulfate-3mg-10ml-solution-for-injection-in-pre-filled-syringe-mdr-18-01-19 2019-02-18T11:07:10+00:00

Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-actavis-group-ptc-ehf-irbesartan-300mg-film-coated-tablets-pl-30306-0108-and-irbesartan-hydrochlorothiazide-300-25mg-film-coated-tablets-pl-30306-0267-mdr-94-06-18 2019-02-13T10:59:40+00:00

Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

tag:www.gov.uk,2005:/drug-device-alerts/recall-of-certain-batches-of-eurotrol-haemoglobin-controls-due-to-microbial-contamination-mda-2019-005 2019-01-30T15:31:22+00:00

Manufactured by Eurotrol B.V � may give readings below the values assigned to the product, leading to incorrect measurement results.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-macleods-pharma-uk-limited-irbesartan-150mg-film-coated-tablets-pl-34771-0079-mdr-94-06-18 2019-01-24T12:14:36+00:00

Macleods Pharma UK Limited is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

tag:www.gov.uk,2005:/drug-device-alerts/datex-ohmeda-aisys-cs2-and-aisys-anaesthesia-devices-with-software-version-11-and-version-11-sp01-service-pack-risk-of-ventilation-loss-inadequate-anaesthesia-and-hypoxia-or-severe-hypotension-mda-2019-001 2019-01-17T11:01:33+00:00

Manufactured by GE Healthcare � Device may stop ventilation when in PSV Pro Mode and users may be unable to change gas and agent settings when using End-Tidal Control.

tag:www.gov.uk,2005:/drug-device-alerts/class-2-medicines-recall-actavis-group-ptc-ehf-recall-of-batches-of-irbesartan-hydrochlorothiazide-300-12-5mg-film-coated-tablets-and-irbesartan-hydrochlorothiazide-150-12-5mg-film-coated-tablets 2019-01-03T12:30:26+00:00

Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notice-17-21-december-2018 2018-12-24T14:21:06+00:00

List of field safety notices (FSNs) from medical device manufacturers from 17 - 21 December 2018

tag:www.gov.uk,2005:/drug-device-alerts/field-safety-notice-10-14-december-2018 2018-12-20T16:22:06+00:00

List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 December 2018