Product recalls | Novartis

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href="/about/executive-committee/fiona-marshall" > <i class="borderH"></i> Fiona Marshall  </a> </li> <li class="we-mega-menu-li" data-level="2" data-element-type="we-mega-menu-li" data-id="127cba96-cf6e-4cf9-9b77-bf2ee6bb3d3c" data-submenu="0" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Klaus Moosmayer" href="/about/executive-committee/klaus-moosmayer" > <i class="borderH"></i> Klaus Moosmayer  </a> </li> <li class="we-mega-menu-li" data-level="2" data-element-type="we-mega-menu-li" data-id="3c2bf703-a1fb-4fa2-ae90-7410406d5d47" data-submenu="0" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Lutz Hegemann" href="/about/executive-committee/lutz-hegemann" > <i class="borderH"></i> Lutz Hegemann  </a> </li> <li class="we-mega-menu-li" data-level="2" data-element-type="we-mega-menu-li" 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title="Novartis quality management system (QMS)" href="/about/quality/novartis-quality-management-system-qms" > <i class="borderH"></i> Novartis quality management system (QMS)  </a> </li> <li class="we-mega-menu-li" data-level="2" data-element-type="we-mega-menu-li" data-id="1c43d8d3-d2b2-46b0-bd57-e2b1fe5a0077" data-submenu="0" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Product and patient safety training" href="/about/quality/product-and-patient-safety-training" > <i class="borderH"></i> Product and patient safety training  </a> </li> <li class="we-mega-menu-li" data-level="2" data-element-type="we-mega-menu-li" data-id="901cc6b8-10c6-49ee-83a1-a3316ea720c5" data-submenu="0" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Regulatory inspections" 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class="we-mega-menu-li" data-level="1" data-element-type="we-mega-menu-li" data-id="23da37d2-b27b-4c8c-9b93-9b1bc88b131d" data-submenu="0" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Awards and recognition" href="/about/awards-and-recognition" > <i class="borderH"></i> Awards and recognition  </a> </li> </ul> </div> <div class="we-mega-menu-col span6" data-element-type="we-mega-menu-col" data-width="6" data-block="polaris_aboutusmegamenu" data-blocktitle="0" data-hidewhencollapse="" data-class=""> <div class="type-of-block"><div class="block-inner"><div class="megamenu-content-block"> <div id="block-polaris-aboutusmegamenu" data-block-plugin-id="block_content:b3e5f886-7b1e-4657-9cdf-7edd29b61713" class="block-content-mega_menu"> <div class="section-image"> <img src="/sites/novartis_com/files/styles/image_mega_menu/public/2023-11/mother-daughter-cuddling-on-a-bed-kid-room-menu.jpg.webp?itok=KmIUz5U9" alt="Mother and daughter cuddling on a bed in a kids room" title="Mother and daughter cuddling on a bed in a kids room"/> </div> <div class="section-content"> <p>About</p> </div> <div class="section-description" > <p><span lang="EN-GB">Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.</span><span lang="EN-GB"></span></p> </div> </div> </div> </div></div> </div> </div> </div> </div> </li> <li class="we-mega-menu-li dropdown-menu" data-level="0" data-element-type="we-mega-menu-li" data-id="46c98121-e544-4ac9-bc64-a92da86975ca" data-submenu="1" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Patients and caregivers" href="/patients-and-caregivers" > <i class="borderH"></i> Patients and caregivers  </a> <div class="we-mega-menu-submenu" data-element-type="we-mega-menu-submenu"> <span class="more_from"></span> <div class="we-mega-menu-submenu-inner"> <div class="we-mega-menu-row" data-element-type="we-mega-menu-row" data-custom-row="1"> <div class="we-mega-menu-col span6" data-element-type="we-mega-menu-col" data-width="6" data-block="" data-blocktitle="0" data-hidewhencollapse="" data-class=""> <ul class="nav 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data-id="0617991d-c0cc-4cdf-a385-b0656846b215" data-submenu="0" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Patient organization funding" href="/investors/reporting-and-transparency-hub/patient-organization-funding" > <i class="borderH"></i> Patient organization funding  </a> </li> <li class="we-mega-menu-li" data-level="1" data-element-type="we-mega-menu-li" data-id="a60978a2-5d32-4919-acce-3930fd343297" data-submenu="0" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Patients perspectives stories" href="/news/stories/patient-perspectives" > <i class="borderH"></i> Patients perspectives stories  </a> </li> </ul> </div> <div class="we-mega-menu-col span6" data-element-type="we-mega-menu-col" data-width="6" data-block="polaris_pastprogramsmegamenu" data-blocktitle="0" data-hidewhencollapse="" data-class=""> <div class="type-of-block"><div class="block-inner"><div class="megamenu-content-block"> <div id="block-polaris-pastprogramsmegamenu" data-block-plugin-id="block_content:ed5e103c-408c-400f-b126-a637a4f8892b" class="block-content-mega_menu"> <div class="section-image"> <img src="/sites/novartis_com/files/styles/image_mega_menu/public/2023-11/daughter-talking-to-senior-parents-on-bench-in-park-menu.jpg.webp?itok=5-8i5oYL" alt="Adult daughter talking to her senior parents on a bench in a park" title="Adult daughter talking to her senior parents on a bench in a park"/> </div> <div class="section-content"> <p>Patients and caregivers</p> </div> <div class="section-description"> <p>Information for patients and their caregivers including clinical trial recruiting, managed access programs, funding opportunities for patient organizations and side effects reporting.</p> </div> </div> </div> </div></div> </div> </div> </div> </div> </li> <li 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Explore the Novartis in Society Integrated Report.</p> </div> </div> </div> </div></div> </div> </div> </div> </div> </li> <li class="we-mega-menu-li dropdown-menu" data-level="0" data-element-type="we-mega-menu-li" data-id="201d99e2-cf92-4d8f-adb4-ba5c192edb83" data-submenu="1" data-group="0" data-class="" data-icon="" data-caption="" data-alignsub="" data-target=""> <i class="borderH"></i> <a class="we-mega-menu-li" title="Investors" href="/investors" > <i class="borderH"></i> Investors  </a> <div class="we-mega-menu-submenu" data-element-type="we-mega-menu-submenu"> <span class="more_from"></span> <div class="we-mega-menu-submenu-inner"> <div class="we-mega-menu-row" data-element-type="we-mega-menu-row" data-custom-row="1"> <div class="we-mega-menu-col span6" data-element-type="we-mega-menu-col" data-width="6" data-block="" data-blocktitle="0" data-hidewhencollapse="" data-class=""> <ul class="nav nav-tabs subul"> <li class="we-mega-menu-li" data-level="1" 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content_middle"> <div class="col-sm-12 content_left_side"> <div class="field_body_txt "> <div class="field field--name-field-body field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--rich-text-content paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-content field--type-text-with-summary field--label-hidden field__item"><p>Novartis maintains a comprehensive process across the entire company to assess quality defects and safety issues and whether a market action (such as a product recall) would be required. Any such occurring incident is escalated through an established company-wide quality assurance process that enables a prompt investigation and assessment by committees consisting of subject-matter experts, quality management, medical safety experts and regulatory responsible persons.</p><p>Conclusions from these committees are provided, with relevant documentation, including a safety assessment, to the competent responsible health authorities in impacted markets. Market actions, e.g., product recalls, will then be executed following an established process as agreed with and endorsed by the respective health authorities.</p></div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--download-cards paragraph--view-mode--default grey_bg"> <div class="container"> <a href="https://www.novartis.com/sites/novartis_com/files/novartis-integrated-report-2023.pdf" target="_blank" rel="noopener noreferrer" class="btm-download link_button" > <span class="file-type pdf"></span> <span class="download_name"> Novartis in Society Integrated Report 2023 <span class="file-size">(9 MB)</span> </span> <span class="downloadButton"></span> </a> </div> </div> </div> </div> </div> </div> </div> <div class="content_bottom"> <div class="clearfix text-formatted field field--name-field-legend field--type-text-with-summary field--label-hidden field__item"><p>References:</p> <ol> <li>Definition of Class I/II recalls is given on the FDA webpage: <a 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