Le 13 octobre 2026, la soci\u00e9t\u00e9 pharmaceutique Par Health USA, LLC (\u00c9tats-Unis, Rochester, Michigan) a annonc\u00e9 le rappel de 22 lots d\u2019Argatroban Injection 250 mg\/2,5 mL (100 mg\/mL), distribu\u00e9s sous les marques Par Health et Endo USA, au niveau des h\u00f4pitaux et des utilisateurs. L\u2019annonce a \u00e9t\u00e9 publi\u00e9e par la Food and Drug Administration (FDA) le 14 octobre 2026, dans le cadre de son dispositif d\u2019information du public sur les rappels de m\u00e9dicaments, sans endorsement de la part de l\u2019agence.<\/p>\n
Le rappel est motiv\u00e9 par la pr\u00e9sence de particules \u00e9trang\u00e8res dans certains lots, identifi\u00e9es comme de la cellulose, du polystyr\u00e8ne, du poly\u00e9thyl\u00e8ne t\u00e9r\u00e9phtalate, des mat\u00e9riaux de bouchon et possiblement de l\u2019acier inoxydable. Selon l\u2019information communiqu\u00e9e, l\u2019administration d\u2019un produit contamin\u00e9 par ces particules est susceptible d\u2019entra\u00eener des effets ind\u00e9sirables graves mettant potentiellement en jeu le pronostic vital, notamment des embolies pulmonaires (obstruction des vaisseaux sanguins pulmonaires), des occlusions d\u2019autres vaisseaux (pouvant conduire \u00e0 une n\u00e9crose tissulaire et \u00e0 des l\u00e9sions d\u2019organes), ainsi qu\u2019une inflammation de la paroi veineuse favorisant la survenue de thromboses. \u00c0 la date de l\u2019annonce, Par Health indique ne pas avoir re\u00e7u de signalement d\u2019effets ind\u00e9sirables li\u00e9s \u00e0 ce rappel.<\/p>\n
Le m\u00e9dicament concern\u00e9, Argatroban Injection 250 mg\/2,5 mL (100 mg\/mL), est un inhibiteur direct de la thrombine indiqu\u00e9 chez l\u2019adulte pour la prophylaxie ou le traitement de la thrombose en cas de thrombop\u00e9nie induite par l\u2019h\u00e9parine (HIT), ainsi que comme anticoagulant chez les patients adultes pr\u00e9sentant ou \u00e0 risque de HIT subissant une intervention coronarienne percutan\u00e9e. Les lots rappel\u00e9s, identifi\u00e9s par diff\u00e9rents num\u00e9ros de lot et dates de p\u00e9remption allant d\u2019octobre 2026 \u00e0 septembre 2027, ont \u00e9t\u00e9 distribu\u00e9s \u00e0 l\u2019\u00e9chelle nationale aux \u00c9tats-Unis, aupr\u00e8s de grossistes et d\u2019h\u00f4pitaux, entre le 30 d\u00e9cembre 2024 et le 5 mai 2026.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont Par Health USA, LLC, en tant que titulaire et distributeur (via Par Pharmaceutical ou Endo USA), et la FDA, qui assure la diffusion de l\u2019annonce au public. Cette situation illustre des enjeux de s\u00e9curit\u00e9 des produits de sant\u00e9 hospitaliers, en particulier pour des m\u00e9dicaments critiques \u00e0 vis\u00e9e anticoagulante, et met en \u00e9vidence l\u2019importance des dispositifs de surveillance de la qualit\u00e9 pharmaceutique et de gestion des rappels, ainsi que de l\u2019information rapide des \u00e9tablissements de sant\u00e9 et des professionnels. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 13 octobre 2026, la soci\u00e9t\u00e9 pharmaceutique Par Health USA, LLC (\u00c9tats-Unis, Rochester, Michigan) a annonc\u00e9 le rappel de 22 lots d\u2019Argatroban Injection 250 mg\/2,5 mL (100 mg\/mL), distribu\u00e9s sous […]<\/p>\n","protected":false},"author":1,"featured_media":17780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[260,227,226],"class_list":["post-20916","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-fda","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20916","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20916"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20916\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17780"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20916"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20916"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20916"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}