{"id":26455,"date":"2022-08-25T17:01:00","date_gmt":"2022-08-25T09:01:00","guid":{"rendered":"https:\/\/flcube.com\/?p=26455"},"modified":"2025-02-12T17:05:14","modified_gmt":"2025-02-12T09:05:14","slug":"nmpa-suspends-ucbs-keppra-over-labeling-issues-prompting-recall","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26455","title":{"rendered":"NMPA Suspends UCB’s Keppra Over Labeling Issues, Prompting Recall"},"content":{"rendered":"\n

The National Medical Products Administration (NMPA) has suspended approval for UCB’s Keppra (levetiracetam) concentrated solution after an overseas inspection uncovered inconsistent expiration date labeling. The decision affects batches manufactured and packaged abroad, with UCB initiating a voluntary recall and cooperating to resolve the issue.<\/p>\n\n\n\n

Company Response<\/strong>
UCB announced the recall of four specific batches of the injectable solution, stating the products are within their valid registration period and pose no safety risks. The firm is working with regulators and overseas facilities to implement corrective measures and resume supply in China.<\/p>\n\n\n\n

Drug Details<\/strong>
Keppra, a pyrrolidone derivative developed by UCB, is used to treat partial seizures in epilepsy patients. Approved in the US in 1999 and launched in China in 2007, it is available as tablets, oral solution, and injectable solution. The injectable form is used when oral administration is not feasible.<\/p>\n\n\n\n

Market Impact<\/strong>
The suspension only impacts the overseas-manufactured concentrated solution, Does not affect the production and supply of other specifications or UCB products. UCB won a tender in China’s third volume-based procurement (VBP) round, securing supply contracts in seven regions. Fineline Info & Tech data shows the drug is sold in multiple forms, with the injectable solution accounting for a smaller share of clinical use.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The National Medical Products Administration (NMPA) has suspended approval for UCB’s Keppra (levetiracetam) concentrated solution…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,4],"tags":[87,697,14,131,82],"class_list":["post-26455","post","type-post","status-publish","format-standard","hentry","category-company","category-policy-regulatory","tag-chronic-disease","tag-gmp-gcp-gsp","tag-nmpa","tag-ucb","tag-vbp-voluem-based-procurement"],"yoast_head":"\nNMPA Suspends UCB's Keppra Over Labeling Issues, Prompting Recall - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The National Medical Products Administration (NMPA) has suspended approval for UCB's Keppra (levetiracetam) concentrated solution after an overseas inspection uncovered inconsistent expiration date labeling. The decision affects batches manufactured and packaged abroad, with UCB initiating a voluntary recall and cooperating to resolve the issue.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=26455\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA Suspends UCB's Keppra Over Labeling Issues, Prompting Recall\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=26455\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2022-08-25T09:01:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-12T09:05:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26455#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26455\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"NMPA Suspends UCB’s Keppra Over Labeling Issues, Prompting Recall\",\"datePublished\":\"2022-08-25T09:01:00+00:00\",\"dateModified\":\"2025-02-12T09:05:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26455\"},\"wordCount\":220,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Chronic disease\",\"GMP \\\/ GCP \\\/ GSP\",\"NMPA\",\"UCB\",\"VBP (voluem-based procurement)\"],\"articleSection\":[\"Company\",\"Policy \\\/ Regulatory\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=26455#respond\"]}],\"copyrightYear\":\"2022\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26455\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=26455\",\"name\":\"NMPA Suspends UCB's Keppra Over Labeling Issues, Prompting Recall - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2022-08-25T09:01:00+00:00\",\"dateModified\":\"2025-02-12T09:05:14+00:00\",\"description\":\"The National Medical Products Administration (NMPA) has suspended approval for UCB's Keppra (levetiracetam) concentrated solution after an overseas inspection uncovered inconsistent expiration date labeling. The decision affects batches manufactured and packaged abroad, with UCB initiating a voluntary recall and cooperating to resolve the issue.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26455#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=26455\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26455#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"NMPA Suspends UCB’s Keppra Over Labeling Issues, Prompting Recall\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"NMPA Suspends UCB's Keppra Over Labeling Issues, Prompting Recall - Insight, China's Pharmaceutical Industry","description":"The National Medical Products Administration (NMPA) has suspended approval for UCB's Keppra (levetiracetam) concentrated solution after an overseas inspection uncovered inconsistent expiration date labeling. The decision affects batches manufactured and packaged abroad, with UCB initiating a voluntary recall and cooperating to resolve the issue.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=26455","og_locale":"en_US","og_type":"article","og_title":"NMPA Suspends UCB's Keppra Over Labeling Issues, Prompting Recall","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=26455","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2022-08-25T09:01:00+00:00","article_modified_time":"2025-02-12T09:05:14+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=26455#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=26455"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"NMPA Suspends UCB’s Keppra Over Labeling Issues, Prompting Recall","datePublished":"2022-08-25T09:01:00+00:00","dateModified":"2025-02-12T09:05:14+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=26455"},"wordCount":220,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Chronic disease","GMP \/ GCP \/ GSP","NMPA","UCB","VBP (voluem-based procurement)"],"articleSection":["Company","Policy \/ Regulatory"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=26455#respond"]}],"copyrightYear":"2022","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=26455","url":"https:\/\/flcube.com\/?p=26455","name":"NMPA Suspends UCB's Keppra Over Labeling Issues, Prompting Recall - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2022-08-25T09:01:00+00:00","dateModified":"2025-02-12T09:05:14+00:00","description":"The National Medical Products Administration (NMPA) has suspended approval for UCB's Keppra (levetiracetam) concentrated solution after an overseas inspection uncovered inconsistent expiration date labeling. The decision affects batches manufactured and packaged abroad, with UCB initiating a voluntary recall and cooperating to resolve the issue.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=26455#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=26455"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=26455#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"NMPA Suspends UCB’s Keppra Over Labeling Issues, Prompting Recall"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26455","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=26455"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26455\/revisions"}],"predecessor-version":[{"id":26456,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26455\/revisions\/26456"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26455"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26455"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}