{"id":30920,"date":"2025-09-12T09:45:42","date_gmt":"2025-09-12T12:45:42","guid":{"rendered":"https:\/\/victoriaaldia.com\/?p=30920"},"modified":"2025-09-12T09:45:42","modified_gmt":"2025-09-12T12:45:42","slug":"anmat-ordeno-el-retiro-de-lotes-de-un-medicamento-oncologico","status":"publish","type":"post","link":"https:\/\/victoriaaldia.com\/?p=30920","title":{"rendered":"ANMAT orden\u00f3 el retiro de lotes de un medicamento oncol\u00f3gico"},"content":{"rendered":"

Bolet\u00edn Oficial<\/h2>\n
La medida preventiva incluye la inhibici\u00f3n de la planta productiva, el retiro de dos lotes de un medicamento oncol\u00f3gico y la apertura de un sumario sanitario.<\/header>\n
<\/header>\n
La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT) dispuso la inhibici\u00f3n preventiva de las actividades de\u00a0Laboratorios Aspen S.A.<\/b>, tras detectar incumplimientos graves a las\u00a0Buenas Pr\u00e1cticas de Fabricaci\u00f3n y Control (BPF)<\/b>. La medida fue oficializada a trav\u00e9s de la\u00a0Disposici\u00f3n 6788\/2025<\/b>, publicada en el Bolet\u00edn Oficial.<\/p>\n

 <\/p>\n

Seg\u00fan se detalla en el expediente, durante una inspecci\u00f3n realizada en la planta ubicada en la calle Remedios 3439 de la Ciudad Aut\u00f3noma de Buenos Aires se identificaron\u00a0deficiencias cr\u00edticas y mayores<\/b>\u00a0en el sistema de gesti\u00f3n de calidad, control de producci\u00f3n, condiciones de equipos e instalaciones, adem\u00e1s de falencias en la capacitaci\u00f3n y responsabilidades del personal.<\/p>\n

 <\/p>\n

Ante este escenario, ANMAT orden\u00f3 a la empresa:<\/p>\n

Inhibir todas sus actividades productivas<\/b>.<\/p>\n

Retirar del mercado<\/b>\u00a0los lotes 135024-1 1034 (vencimiento 01\/2026) y 138724-1 1034 (vencimiento 01\/2026) del producto\u00a0Tazadir\/Azacitidina 100 mg inyectable liofilizado<\/b>\u00a0(Certificado N\u00b0 55588), por haberse detectado irregularidades en controles de calidad y materias primas no validadas.<\/p>\n

\"ANMAT\"
ANMAT<\/figcaption><\/figure>\n

Someterse a un sumario sanitario<\/b>\u00a0junto con su direcci\u00f3n t\u00e9cnica, por presunta infracci\u00f3n a la normativa vigente.<\/p>\n

 <\/p>\n

El organismo regulador fundament\u00f3 su decisi\u00f3n en la\u00a0p\u00e9rdida de garant\u00edas de calidad, seguridad y eficacia<\/b>\u00a0de los medicamentos fabricados, lo que podr\u00eda comprometer la salud de los pacientes.<\/p>\n

 <\/p>\n

Asimismo, se instruy\u00f3 a la firma a presentar la documentaci\u00f3n respaldatoria de las acciones de recupero y se notific\u00f3 a las autoridades sanitarias provinciales y de la Ciudad de Buenos Aires. Fuente: El Once<\/p>\n

\"\"<\/a><\/p>\n<\/header>\n","protected":false},"excerpt":{"rendered":"

Bolet\u00edn Oficial La medida preventiva incluye la inhibici\u00f3n de la planta productiva, el retiro de dos lotes de un medicamento oncol\u00f3gico y la apertura de un sumario sanitario. La Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica (ANMAT) dispuso la…<\/p>\n","protected":false},"author":3,"featured_media":30921,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[],"class_list":["post-30920","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nacionales","category-noticias"],"yoast_head":"\nANMAT orden\u00f3 el retiro de lotes de un medicamento oncol\u00f3gico - Victoria Al D\u00eda<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/victoriaaldia.com\/?p=30920\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANMAT orden\u00f3 el retiro de lotes de un medicamento oncol\u00f3gico - Victoria Al D\u00eda\" \/>\n<meta property=\"og:description\" content=\"Bolet\u00edn Oficial La medida preventiva incluye la inhibici\u00f3n de la planta productiva, el retiro de dos lotes de un medicamento oncol\u00f3gico y la apertura de un sumario sanitario. 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