Le 8 octobre 2026, l\u2019entreprise Par Health, bas\u00e9e \u00e0 Rochester (Michigan, \u00c9tats-Unis), a annonc\u00e9 un rappel volontaire de deux lots du m\u00e9dicament Brevital Sodium 500 mg\/vial CIV (Methohexital Sodium for Injection, USP), un anesth\u00e9sique barbiturique \u00e0 action ultra-rapide utilis\u00e9 pour l\u2019induction de l\u2019anesth\u00e9sie et la s\u00e9dation proc\u00e9durale. L\u2019annonce a \u00e9t\u00e9 rendue publique par la Food and Drug Administration (FDA) le 9 octobre 2026 dans le cadre de son dispositif d\u2019information sur les rappels, retraits de march\u00e9 et alertes de s\u00e9curit\u00e9 de produits de sant\u00e9. La FDA pr\u00e9cise qu\u2019elle se limite \u00e0 publier le communiqu\u00e9 de l\u2019entreprise et ne cautionne ni le produit ni la soci\u00e9t\u00e9.<\/p>\n
Le rappel est motiv\u00e9 par la pr\u00e9sence de particules identifi\u00e9es comme \u00e9tant de la cellulose dans certaines unit\u00e9s du produit. Selon l\u2019information diffus\u00e9e, l\u2019administration d\u2019un lot contamin\u00e9 est susceptible d\u2019entra\u00eener des cons\u00e9quences graves pour la sant\u00e9, incluant un risque raisonnable d\u2019\u00e9v\u00e9nements potentiellement mortels tels que des embolies pulmonaires (obstruction des vaisseaux sanguins pulmonaires), des occlusions d\u2019autres vaisseaux sanguins pouvant conduire \u00e0 une n\u00e9crose tissulaire et des l\u00e9sions d\u2019organes, ainsi qu\u2019une inflammation de la paroi veineuse pouvant favoriser la formation de caillots. \u00c0 la date de l\u2019annonce, Par Health indique ne pas avoir re\u00e7u de signalement d\u2019\u00e9v\u00e9nement ind\u00e9sirable en lien avec ce rappel.<\/p>\n
Les lots concern\u00e9s sont identifi\u00e9s sous la d\u00e9nomination Brevital Sodium 500 mg\/vial CIV (Methohexital Sodium for Injection, USP), distribu\u00e9s par Par Pharmaceutical, avec les codes et num\u00e9ros de lot suivants : taille 500 mg\/vial, item code 42023-105-01, lots n\u00b0 86930 (p\u00e9remption 02\/2028) et 88623 (p\u00e9remption 04\/2028). Ces lots ont \u00e9t\u00e9 distribu\u00e9s \u00e0 l\u2019\u00e9chelle nationale aux \u00c9tats-Unis, aupr\u00e8s de grossistes, entre le 8 juillet 2025 et le 11 mai 2026. Le m\u00e9dicament est destin\u00e9 \u00e0 une administration par perfusion intraveineuse chez l\u2019adulte et par voie intramusculaire pour l\u2019induction anesth\u00e9sique chez l\u2019enfant.<\/p>\n
Par Health indique avoir engag\u00e9 une proc\u00e9dure de notification \u00e9crite \u00e0 l\u2019ensemble des grossistes ayant re\u00e7u les lots concern\u00e9s et organise, via la soci\u00e9t\u00e9 Inmar, Inc., la reprise de tous les stocks de ces lots. Les distributeurs en gros et les pharmacies hospitali\u00e8res sont invit\u00e9s \u00e0 cesser imm\u00e9diatement l\u2019utilisation et la distribution du produit rappel\u00e9. En cas de redistribution en aval, les \u00e9tablissements sont pri\u00e9s d\u2019informer sans d\u00e9lai leurs propres clients ou sites ayant pu recevoir les lots en question. L\u2019annonce met en \u00e9vidence les enjeux de surveillance de la qualit\u00e9 pharmaceutique des m\u00e9dicaments injectables et les risques sp\u00e9cifiques li\u00e9s \u00e0 la pr\u00e9sence de particules dans des produits administr\u00e9s par voie intraveineuse ou intramusculaire. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 8 octobre 2026, l\u2019entreprise Par Health, bas\u00e9e \u00e0 Rochester (Michigan, \u00c9tats-Unis), a annonc\u00e9 un rappel volontaire de deux lots du m\u00e9dicament Brevital Sodium 500 mg\/vial CIV (Methohexital Sodium for […]<\/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-20461","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\/20461","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=20461"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20461\/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=20461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}