{"id":8260,"date":"2015-02-23T18:32:00","date_gmt":"2015-02-24T02:32:00","guid":{"rendered":"http:\/\/www.foodanddrugrecall.org\/index.php\/sagent-pharmaceuticals-initiates-a-nationwide-voluntary-recall-of-atracurium-besylate-injection-usp-50mg5ml-and-100mg10ml-due-to-fda-observations-pertaining-toaseptic-and-gmp-practices-at-the-manu\/"},"modified":"2015-02-23T18:32:00","modified_gmt":"2015-02-24T02:32:00","slug":"sagent-pharmaceuticals-initiates-a-nationwide-voluntary-recall-of-atracurium-besylate-injection-usp-50mg5ml-and-100mg10ml-due-to-fda-observations-pertaining-toaseptic-and-gmp-practices-at-the-manu","status":"publish","type":"post","link":"https:\/\/www.foodanddrugrecall.org\/index.php\/sagent-pharmaceuticals-initiates-a-nationwide-voluntary-recall-of-atracurium-besylate-injection-usp-50mg5ml-and-100mg10ml-due-to-fda-observations-pertaining-toaseptic-and-gmp-practices-at-the-manu\/","title":{"rendered":"Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg\/5mL and 100mg\/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer\u2019s Site Potentially Impacting Product Sterility"},"content":{"rendered":"<p>Schaumburg, IL,Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg\/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg\/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg\/5mL and 100mg\/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer\u2019s site potentially impacting product sterility. Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Schaumburg, IL,Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg\/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg\/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, &hellip; <a href=\"https:\/\/www.foodanddrugrecall.org\/index.php\/sagent-pharmaceuticals-initiates-a-nationwide-voluntary-recall-of-atracurium-besylate-injection-usp-50mg5ml-and-100mg10ml-due-to-fda-observations-pertaining-toaseptic-and-gmp-practices-at-the-manu\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg\/5mL and 100mg\/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer\u2019s Site Potentially Impacting Product Sterility<\/span> <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"1","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-8260","post","type-post","status-publish","format-standard","hentry","category-food-drug-recalls"],"_links":{"self":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/posts\/8260","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/comments?post=8260"}],"version-history":[{"count":0,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/posts\/8260\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/media?parent=8260"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/categories?post=8260"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.foodanddrugrecall.org\/index.php\/wp-json\/wp\/v2\/tags?post=8260"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}