Le 17 septembre 2026, l\u2019entreprise pharmaceutique Otsuka ICU Medical LLC, bas\u00e9e \u00e0 Austin (Texas), a annonc\u00e9 un rappel volontaire d\u2019un lot de solution injectable de chlorure de sodium 0,9 % (Injection, USP, poche de 100 mL, NDC 0990-7984-23, lot 1042188) au niveau des utilisateurs. L\u2019annonce a \u00e9t\u00e9 rendue publique par la Food and Drug Administration (FDA) des \u00c9tats-Unis le 21 septembre 2026. La mesure fait suite \u00e0 un signalement de client faisant \u00e9tat d\u2019une poche de 100 mL de chlorure de potassium hautement concentr\u00e9 \u00e0 10 mEq (POTASSIUM CHLORIDE Inj. 10 mEq, NDC 0990-7074-26, lot 1035181) trouv\u00e9e \u00e0 l\u2019int\u00e9rieur d\u2019un suremballage \u00e9tiquet\u00e9 comme contenant du chlorure de sodium 0,9 %.<\/p>\n
Le probl\u00e8me identifi\u00e9 correspond \u00e0 un risque de \u00ab mix-up \u00bb : l\u2019emballage ext\u00e9rieur mentionne une solution de chlorure de sodium 0,9 %, alors que le produit r\u00e9el est une solution concentr\u00e9e de chlorure de potassium \u00e0 10 mEq. Le produit incorrect comporte n\u00e9anmoins sa propre \u00e9tiquette interne indiquant clairement \u00ab POTASSIUM CHLORIDE Inj. 10 mEq \u00bb. Le lot concern\u00e9 a \u00e9t\u00e9 fabriqu\u00e9 le 13 novembre 2025 et distribu\u00e9 aux \u00c9tats-Unis entre le 30 d\u00e9cembre 2025 et le 22 juin 2026.<\/p>\n
Selon l\u2019analyse de risque pr\u00e9sent\u00e9e, l\u2019injection involontaire de chlorure de potassium hautement concentr\u00e9 peut entra\u00eener des \u00e9v\u00e9nements ind\u00e9sirables graves et potentiellement mortels. Les populations les plus \u00e0 risque incluent notamment les pr\u00e9matur\u00e9s, les patients sous nutrition parent\u00e9rale chronique, ceux pr\u00e9sentant des ant\u00e9c\u00e9dents d\u2019arythmies cardiaques, une insuffisance r\u00e9nale chronique ou aigu\u00eb, ainsi que les patients sous diur\u00e9tiques \u00e9pargneurs de potassium. Les effets possibles mentionn\u00e9s incluent des dysfonctionnements neuromusculaires (faiblesse musculaire, paralysie ascendante, apathie), des troubles neurologiques (vertiges, confusion mentale), une hypotension, des troubles du rythme cardiaque et un arr\u00eat cardiaque pouvant \u00eatre fatal. \u00c0 la date de l\u2019annonce, Otsuka ICU Medical LLC indique ne pas avoir re\u00e7u de signalement d\u2019\u00e9v\u00e9nements ind\u00e9sirables li\u00e9s \u00e0 ce rappel.<\/p>\n
Les acteurs principaux mentionn\u00e9s sont Otsuka ICU Medical LLC, en tant que fabricant et initiateur du rappel volontaire, et la FDA am\u00e9ricaine, qui publie l\u2019annonce \u00e0 titre de service public sans endosser le produit ni l\u2019entreprise. L\u2019incident illustre un risque de s\u00e9curit\u00e9 m\u00e9dicamenteuse li\u00e9 \u00e0 des erreurs d\u2019\u00e9tiquetage et de conditionnement, avec des implications en mati\u00e8re de gestion des risques dans les \u00e9tablissements de sant\u00e9, de proc\u00e9dures de contr\u00f4le qualit\u00e9 industriel et de pharmacovigilance, pouvant pr\u00e9senter un int\u00e9r\u00eat pour les autorit\u00e9s fran\u00e7aises dans une perspective de veille et de comparaison internationale des pratiques de s\u00e9curisation du circuit du m\u00e9dicament injectable. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 17 septembre 2026, l\u2019entreprise pharmaceutique Otsuka ICU Medical LLC, bas\u00e9e \u00e0 Austin (Texas), a annonc\u00e9 un rappel volontaire d\u2019un lot de solution injectable de chlorure de sodium 0,9 % […]<\/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-18140","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\/18140","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=18140"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18140\/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=18140"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18140"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18140"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}