{"id":1934,"date":"2025-04-04T19:18:00","date_gmt":"2025-04-04T18:18:00","guid":{"rendered":"https:\/\/tufarmaciavirtual.com\/blog\/?p=1934"},"modified":"2025-07-04T19:18:45","modified_gmt":"2025-07-04T18:18:45","slug":"alerta-ema-2025-retiros-recientes-de-medicamentos-y-lotes-por-calidad-o-seguridad","status":"publish","type":"post","link":"https:\/\/tufarmaciavirtual.com\/blog\/alerta-ema-2025-retiros-recientes-de-medicamentos-y-lotes-por-calidad-o-seguridad\/","title":{"rendered":"ALERTA EMA 2025: Retiros recientes de medicamentos y lotes por calidad o seguridad"},"content":{"rendered":"\n<p class=\"has-ast-global-color-6-background-color has-background\">Cada a\u00f1o, la Agencia Europea del Medicamento (EMA) y las autoridades nacionales de farmacovigilancia publican alertas y retiradas de medicamentos por motivos de calidad, seguridad o problemas en la fabricaci\u00f3n. En 2025, varios f\u00e1rmacos han sido objeto de medidas preventivas que conviene conocer. Desde <a href=\"http:\/\/www.tufarmaciavirtual.com\">nuestra farmacia <\/a>te informamos sobre los <strong>\u00faltimos retiros de medicamentos y lotes afectados<\/strong>, y te orientamos sobre qu\u00e9 hacer si est\u00e1s en tratamiento con alguno de ellos.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83e\uddfe \u00bfPor qu\u00e9 se retira un medicamento o lote?<\/h2>\n\n\n\n<p>Un medicamento puede ser retirado del mercado de forma temporal o permanente por razones como:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Impurezas o contaminaci\u00f3n<\/strong> durante la fabricaci\u00f3n<\/li>\n\n\n\n<li><strong>Defectos en el etiquetado o en el acondicionamiento<\/strong><\/li>\n\n\n\n<li><strong>Fallo en la estabilidad del principio activo<\/strong><\/li>\n\n\n\n<li><strong>Riesgos detectados en la farmacovigilancia post-comercializaci\u00f3n<\/strong><\/li>\n\n\n\n<li><strong>Decisiones del fabricante por motivos regulatorios o log\u00edsticos<\/strong><\/li>\n<\/ul>\n\n\n\n<p>En la mayor\u00eda de los casos, se trata de <strong>retiradas preventivas por seguridad<\/strong>, sin que se hayan producido da\u00f1os directos en pacientes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83d\udea8 Retiradas destacadas en 2025 (primer semestre)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. <strong>Valsart\u00e1n (varios gen\u00e9ricos)<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Motivo<\/strong>: presencia de impurezas nitrosaminas por encima del umbral permitido.<\/li>\n\n\n\n<li><strong>Lotes afectados<\/strong>: notificados por varios laboratorios con distribuci\u00f3n en Espa\u00f1a, Francia y Alemania.<\/li>\n\n\n\n<li><strong>Recomendaci\u00f3n<\/strong>: sustituir por otros lotes o principios activos alternativos como candesart\u00e1n.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. <strong>Lote defectuoso de Levotiroxina 100 mcg<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Laboratorio<\/strong>: f\u00f3rmula com\u00fanmente utilizada para hipotiroidismo.<\/li>\n\n\n\n<li><strong>Motivo<\/strong>: error en la uniformidad del contenido del principio activo.<\/li>\n\n\n\n<li><strong>Riesgo<\/strong>: ineficacia o sobredosificaci\u00f3n.<\/li>\n\n\n\n<li><strong>Medida<\/strong>: retirada completa del lote afectado en farmacias y centros de salud.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. <strong>Suspensi\u00f3n preventiva de lotes de Amoxicilina pedi\u00e1trica en jarabe<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Motivo<\/strong>: defecto en el sistema de cierre del frasco que compromete la estabilidad del antibi\u00f3tico.<\/li>\n\n\n\n<li><strong>Acci\u00f3n<\/strong>: retirada de stock y sustituci\u00f3n inmediata.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. <strong>Ranitidina (sigue sin autorizaci\u00f3n en 2025)<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Aunque su retirada fue en a\u00f1os anteriores, <strong>contin\u00faan circulando productos no autorizados en algunas plataformas digitales ilegales<\/strong>.<\/li>\n\n\n\n<li><strong>Recomendaci\u00f3n<\/strong>: no adquirir medicamentos por internet fuera de farmacias reguladas.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83e\uddd1\u200d\u2695\ufe0f \u00bfQu\u00e9 hacer si estoy usando uno de estos medicamentos?<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Revisa el n\u00famero de lote<\/strong> y fecha de caducidad del envase.<\/li>\n\n\n\n<li><strong><a href=\"https:\/\/api.whatsapp.com\/send\/?phone=376685271&amp;text=Hola%2C+quisiera+hacer+una+consulta&amp;type=phone_number&amp;app_absent=0\">Consulta a tu farmac\u00e9utico<\/a><\/strong> para confirmar si tu caja est\u00e1 entre las afectadas.<\/li>\n\n\n\n<li><strong>Nunca suspendas el tratamiento por tu cuenta.<\/strong> El farmac\u00e9utico te puede ofrecer una alternativa equivalente.<\/li>\n\n\n\n<li><strong>Conserva siempre el prospecto y el envase original<\/strong> hasta finalizar el tratamiento.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">\ud83d\udce2 Consejo farmac\u00e9utico<\/h2>\n\n\n\n<p>Las retiradas de medicamentos no significan que un f\u00e1rmaco no sea seguro, sino que <strong>el sistema de farmacovigilancia est\u00e1 funcionando correctamente<\/strong>. En<a href=\"http:\/\/www.tufarmaciavirtual.com\"> nuestra farmacia<\/a>, revisamos cada alerta oficial publicada por la AEMPS (Espa\u00f1a), ANSM (Francia) y EMA, y actuamos con rapidez para proteger tu salud.<\/p>\n\n\n\n<p>Si tienes dudas sobre la calidad de tu tratamiento o necesitas un cambio urgente, <strong>acude a la farmacia cuanto antes. Estamos para ayudarte.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><a href=\"https:\/\/api.whatsapp.com\/send\/?phone=376685271&amp;text=Hola%2C+quisiera+hacer+una+consulta&amp;type=phone_number&amp;app_absent=0\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"768\" src=\"https:\/\/tufarmaciavirtual.com\/blog\/wp-content\/uploads\/2025\/07\/image-1.png\" alt=\"\" class=\"wp-image-1924\" srcset=\"https:\/\/tufarmaciavirtual.com\/blog\/wp-content\/uploads\/2025\/07\/image-1.png 1024w, https:\/\/tufarmaciavirtual.com\/blog\/wp-content\/uploads\/2025\/07\/image-1-300x225.png 300w, https:\/\/tufarmaciavirtual.com\/blog\/wp-content\/uploads\/2025\/07\/image-1-768x576.png 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Cada a\u00f1o, la Agencia Europea del Medicamento (EMA) y las autoridades nacionales de farmacovigilancia publican alertas y retiradas de medicamentos 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