{"id":29414,"date":"2017-01-12T17:49:44","date_gmt":"2017-01-12T16:49:44","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=29414"},"modified":"2017-01-12T17:50:30","modified_gmt":"2017-01-12T16:50:30","slug":"aifa-ritiro-cautelativo-generico-metformina-prodotto-india","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/aifa-ritiro-cautelativo-generico-metformina-prodotto-india\/","title":{"rendered":"AIFA. Generic metformin cautionary recall made in India"},"content":{"rendered":"<h1 id=\"page-title\">Cautionary withdrawal lots METFORMIN MYLAN Generic tablets (various strengths)<\/h1>\n<p>L<img loading=\"lazy\" decoding=\"async\" class=\"alignright\" src=\"http:\/\/www.rxresource.org\/image.php?src=1116d85b-f6e2-4f84-845a-f5ee7e12b27c\/1116d85b-f6e2-4f84-845a-f5ee7e12b27c-03.jpg\" alt=\"Risultati immagini per METFORMINA MYLAN GENERICs\" width=\"321\" height=\"117\" \/>The Italian Medicines Agency (AIFA) announces that it has endorsed the voluntary withdrawal by the company that holds the MA of METFORMINA MYLAN GENERICS tablets, in the different dosages, lots specified in the attached provision. The withdrawal is precautionary, is not related to safety or efficacy issues and was issued following an inspection carried out by the Portuguese authority (Infarmed) at the manufacturing plant of the medicine in India which highlighted the non-compliance with the Good Manufacturing Practices (GMP) of the production site. At the moment in the Net of <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/it\/glossary\/term\/1454\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Complex of activities aimed at continuously evaluating all information relating to the safety of medicines and ensuring, for all medicines on the market, a favorable benefit\/risk ratio for the population.\">Pharmacovigilance<\/dfn><\/a> there are no reports of adverse reactions to medicinal products in matters that may be related to the quality defects found by the Portuguese agency.<\/p>\n<p><em>Light:<\/em><\/p>\n<ul>\n<li><em><a href=\"http:\/\/www.agenziafarmaco.gov.it\/sites\/default\/files\/Comunicazione_ritiro_METFORMINA_MYLAN.pdf\" target=\"_blank\" rel=\"noopener\">METFORMIN MYLAN withdrawal communication<\/a><\/em><\/li>\n<li><em><a href=\"http:\/\/www.agenziafarmaco.gov.it\/sites\/default\/files\/Elenco_lotti_ritirati.pdf\" target=\"_blank\" rel=\"noopener\">List of retired lots<\/a><\/em><\/li>\n<\/ul>\n<p><a href=\"http:\/\/www.agenziafarmaco.gov.it\/it\/content\/ritiro-cautelativo-lotti-metformina-mylan-generic-compresse-dosaggi-vari\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #0000ff;\">AIFA press release \u2013 12\/01\/2017<\/span><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Ritiro cautelativo lotti METFORMINA MYLAN GENERIC compresse (dosaggi vari) L\u2019Agenzia Italiana del Farmaco (AIFA) comunica di aver avallato il ritiro volontario da parte dell\u2019azienda titolare dell\u2019AIC di METFORMINA MYLAN GENERICS compresse, nei diversi dosaggi, lotti specificati nel provvedimento in allegato. Il ritiro \u00e8 cautelativo, non \u00e8 collegato a problematiche di sicurezza o di efficacia ed &hellip;<\/p>","protected":false},"author":4,"featured_media":4465,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[49,55,31,91],"class_list":["post-29414","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie","tag-aifa","tag-farmacovigilanza","tag-generici","tag-india"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/29414","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=29414"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/29414\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/4465"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=29414"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=29414"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=29414"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}