{"id":198935,"date":"2025-09-04T07:07:14","date_gmt":"2025-09-04T07:07:14","guid":{"rendered":"https:\/\/www.europesays.com\/us\/198935\/"},"modified":"2025-09-04T07:07:14","modified_gmt":"2025-09-04T07:07:14","slug":"fda-finds-amneal-pharma-used-contaminated-iv-bags-for-sterile-drug","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/198935\/","title":{"rendered":"FDA finds Amneal Pharma used contaminated IV bags for sterile drug"},"content":{"rendered":"<p>In a startling failure of quality control, Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug even after identifying the risk and then lowered its standards so that the bags could continue to be used, according to an Aug. 27 warning letter issued by the U.S. Food and Drug Administration.<\/p>\n<p>The problem was identified during an agency inspection last March at a facility in India run by the company, which is a large supplier of generic and specialty medicines. At the time, FDA inspectors noted that employees failed to investigate the presence of white polypropylene fibers that were found in bags used to hold ropivacaine hydrochloride, which is injected into the epidural space.<\/p>\n<p>The agency complained that Amneal \u201cminimized the severity\u201d of the issue in different ways. For one, it said, the company was aware of the risk of particle contamination from the polypropylene bags, which were purchased from a supplier, for more than a year before an internal investigation was conducted in 2024. In fact, Amneal had rejected several batches after investigating the problem in late 2022 and early 2023.<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" target=\"_blank\" rel=\"noopener\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/06\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" target=\"_blank\" rel=\"noopener\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 plus in-depth analysis, newsletters, premium events, and news alerts.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" target=\"_blank\" rel=\"noopener\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" target=\"_blank\" rel=\"noopener\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" target=\"_blank\" rel=\"noopener\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"In a startling failure of quality control, Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug&hellip;\n","protected":false},"author":3,"featured_media":198936,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[150,151,210,1060,152,881,154,67,132,68],"class_list":{"0":"post-198935","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-biotechnology","9":"tag-fda","10":"tag-health","11":"tag-medication","12":"tag-pharmaceuticals","13":"tag-public-health","14":"tag-stat","15":"tag-united-states","16":"tag-unitedstates","17":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115144769177411579","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/198935","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=198935"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/198935\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/198936"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=198935"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=198935"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=198935"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}