tag:www.gov.uk,2005:/drug-device-alerts 2024-09-30T13:15:15+01:00 HM Government 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 Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.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/cpt-hip-system-femoral-stem-12-slash-14-neck-taper-increased-risk-of-postoperative-periprosthetic-femoral-fracture-dsi-slash-2024-slash-007 2024-09-04T11:02:03+01:00

Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a sim�

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/symbios-origin-r-posterior-stabilised-patient-matched-total-knee-replacement-device-risk-of-early-revision-dsi-slash-2024-slash-005 2024-04-23T11:31:22+01:00

The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.

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/magec-x-system-nuvasive-specialized-orthopedics-nso-uk-suspension-lifted-dsi-slash-2024-slash-002 2024-03-12T15:12:07+00:00

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-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/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/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 ÄŒeska 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/nuvasive-specialized-orthopedics-nso-precice-titanium-systems-uk-suspension-lifted-dsi-2023-slash-006 2023-04-12T09:59:41+01:00

The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte �

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/nexgen-knee-replacement-affected-patients-should-be-offered-additional-follow-up 2023-02-15T12:43:56+00:00

The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Fem�

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/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/recall-of-bd-venflon-pro-safety-iv-cannula 2021-05-20T11:14:17+01:00

Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.

tag:www.gov.uk,2005:/drug-device-alerts/targeted-communication-ce-mark-suspended-for-all-magec-systems-manufactured-by-nuvasive-specialized-orthopedics-inc 2021-05-10T15:51:13+01:00

Recommendations for clinicians including not implanting these devices

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/targeted-letter-implantable-orthopaedic-devices-manufactured-by-implants-international-ltd-trading-as-xtremity-solutions-ltd 2021-02-26T15:30:24+00:00

Unknown risks following distribution of product after CE certificate withdrawal

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/spinal-fixation-system-risk-of-implant-failure-prior-to-completion-of-bone-healing-mda-2020-020 2020-07-10T10:30:51+01:00

Manufactured by Synthes GmbH � cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.

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/spinal-implant-all-magec-systems-supply-suspended-to-the-uk-mda-2020-011 2020-04-01T15:15:14+01:00

Manufactured by NuVasive Specialized Orthopedics � supply of all MAGEC rods suspended to the UK market during a review by MHRA.

tag:www.gov.uk,2005:/drug-device-alerts/spinal-implant-magec-system-model-x-rods-risk-of-failure-in-use-mda-2020-010 2020-03-18T14:09:20+00:00

Manufactured by NuVasive Inc. � risk of end cap separation after implantation.

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/field-safety-notice-08-12-april-2019 2019-04-15T13:18:04+01:00

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 April 2019

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/enflow-iv-fluid-and-blood-warmer-risk-of-unsafe-levels-of-aluminium-leaching-from-the-device-mda-2019-015 2019-03-08T11:03:01+00:00

[Archived] Manufactured by Vyaire � Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

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.