{"id":10192,"date":"2025-03-01T14:03:04","date_gmt":"2025-03-01T19:03:04","guid":{"rendered":"https:\/\/dhss.delaware.gov\/dph\/dhan229\/"},"modified":"2025-03-02T00:49:53","modified_gmt":"2025-03-02T05:49:53","slug":"dhan229","status":"publish","type":"page","link":"https:\/\/dhss.delaware.gov\/dph\/php\/alerts\/dhan229\/","title":{"rendered":"php\/alerts\/dhan229 ~  Division of Public Health &#8211; &#8211; Health Alert  &#8211; Delaware Health and Social Services &#8211; State of Delaware"},"content":{"rendered":"<div data-swiftype-index=\"true\">\n\n\n\n  <br>\n\n\n\n  <div class=\"container\" id=\"main_header\"> \n\n    <!-- BEGIN readspeaker div -->\n\n    <div class=\"rs_skip rsbtn rs_preserve\" id=\"readspeaker_button1\">\n\n      <a accesskey=\"L\" class=\"rsbtn_play\" href=\"https:\/\/app-na.readspeaker.com\/cgi-bin\/rsent?customerid=7262&#038;lang=en_us&#038;readid=main_content&#038;url=https:\/\/dhss.delaware.gov\/dph\/php\/alerts\/dhan229.html\" title=\"Listen to this page using ReadSpeaker\">\n\n        <span class=\"rsbtn_left rsimg rspart\"><span class=\"rsbtn_text\"><span>Listen<\/span><\/span><\/span>\n\n        <span class=\"rsbtn_right rsimg rsplay rspart\"><\/span>\n\n      <\/a>\n\n    <\/div>\n\n    <!-- END readspeaker div -->\n\n\n\n    \n\n    <header class=\"pull-left\">\n\n      <h1>Delaware Health Alert Network #<!--[type=EDIT name=\"DHAN Number\"]-->229 <!--[END]--> <\/h1>\n\n      <h2> <!--[type=EDIT name=\"DHAN Date\"]-->June 1, 2010 11:17am <!--[END]--> <\/h2>\n\n    <\/header>\n\n  <\/div><br>\n\n \n\n  <div class=\"container\">\n\n    <div class=\"row\">\n\n      <div class=\"col-md-3\" id=\"leftCol\">\n\n        <div class=\"panel-group\" id=\"accordion\">\n\n          <div class=\"panel sectionmenu_panel\">\n\n            <div class=\"panel-heading\">\n\n              <p class=\"panel-title\"><a class=\"agency_nav\" data-parent=\"#accordion\" data-toggle=\"collapse\" href=\"#collapseOne\"><strong><i class=\"fa fa-align-justify fa-fw\"><\/i> Public Health Menu<\/strong><\/a><\/p>\n\n            <\/div>\n\n\n\n            <div class=\"panel-collapse collapse in\" id=\"collapseOne\">\n\n              <div class=\"panel-body\" id=\"clf_nav\">\n\n                  <ul class=\"nav nav-stacked nav-pills-clf\" id=\"agency_sidebar\">\n    <li><a href=\"\/dph\/\"><h2>Home <i class=\"fa fa-home fa-fw\"><\/i><\/h2><\/a><\/li>\n    <li class=\"toplevel\"><a data-parent=\"#agency_sidebar\" data-toggle=\"collapse\" href=\"#HomeMenu\"><h2>About <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n      <ul class=\"panel-collapse collapse\" id=\"HomeMenu\">\n        <li><a href=\"\/dph\/about.html\">About DPH<\/a><\/li>\n        <li><a href=\"\/dph\/sections.html\">Sections &#038; 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Wellness<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/healthyhomes.html\">Healthy Homes<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/healthywp.html\">Healthy Workplaces<\/a><\/li>\n        <li><a href=\"\/dph\/lab\/labs.html\">Laboratory<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/feir.html\">Restaurant Inspections<\/a><\/li>\n        <li><a href=\"\/dph\/screen.html\">Screening and Testing<\/a><\/li>\n        <li><a href=\"\/dph\/chca\/dphwichominf01.html\">WIC<\/a><\/li>\n        <li><a href=\"\/dph\/servicesadd.html\">Additional Services<\/a><\/li><li>\n      <\/li><\/ul>\n    <\/li>\n    <li class=\"toplevel\"><a data-parent=\"#sidebar\" data-toggle=\"collapse\" href=\"#InformationMenu\"><h2>Information <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n        <ul class=\"panel-collapse collapse\" id=\"InformationMenu\">\n        <li><a href=\"\/dph\/factsheetsaz.html\">A-Z Fact Sheets<\/a><\/li>\n        <li><a href=\"\/dph\/pubreportsaz.html\">A-Z Publications &#038; Reports<\/a><\/li>\n        <li><a href=\"\/dph\/diseasesandconditions.html\">Diseases &#038; 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FDA has received reports of floating matter in IV bags\n\n\n  manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Microbiological analysis identified the matter in one of the bags as a\n\n\n  <em>Cladosporium<\/em> mold. Molds of this type can cause infections in susceptible patients, such as immunocompromised individuals. At\n\n\n  this time, FDA is not aware of any reports of injuries due to administration of these products. Affected products include any\n\n\n  metronidazole, ondansetron, and ciprofloxacin manufactured by Claris Lifesciences Limited and sold under the following labels: Claris,\n\n\n  Sagent Pharmaceuticals, Pfizer, West-Ward Pharmaceuticals.\n\n\n<\/p>\n\n\n<h3>\n\n\n  Background\n\n\n<\/h3>\n\n\n<p>\n\n\n  Metronidazole and ciprofloxacin are antibiotics used to treat a variety of infections. Ondansetron is an antiemetic used to treat nausea\n\n\n  and vomiting associated with chemotherapy or surgery. A complaint of white matter in a bag of metronidazole was received, and subsequent\n\n\n  microbiological analysis identified the matter as a <em>Cladosporium<\/em> mold. Molds of this type can cause infections in susceptible\n\n\n  patients, such as immunocompromised individuals. Another complaint of white matter in a bag of ondansetron was received and that bag is\n\n\n  currently under analysis. Foreign matter should not be present in a sterile injectable product.\n\n\n<\/p>\n\n\n<h3>\n\n\n  Recommendations\n\n\n<\/h3>\n\n\n<p>\n\n\n  While FDA is learning more about the situation, healthcare professionals should NOT use and should immediately remove from their pharmacy\n\n\n  inventories any metronidazole, ondansetron, and ciprofloxacin intravenous bags sold under the following labels:\n\n\n<\/p>\n\n\n<ul>\n\n\n  <li>\n\n\n    <strong>Claris<\/strong>\n\n\n  <\/li>\n\n\n  <li>\n\n\n    <strong>Sagent Pharmaceuticals<\/strong>\n\n\n  <\/li>\n\n\n  <li>\n\n\n    <strong>Pfizer<\/strong>\n\n\n  <\/li>\n\n\n  <li>\n\n\n    <strong>West\u2013Ward Pharmaceuticals<\/strong>\n\n\n  <\/li>\n\n\n<\/ul>\n\n\n<p>\n\n\n  Only metronidazole, ciprofloxacin, and ondansetron in IV bags sold under the Claris, Sagent, Pfizer, and West-Ward Pharmaceuticals labels\n\n\n  are affected. Claris is initiating a recall of all lots of these products. These products were all manufactured on the same production\n\n\n  line.\n\n\n<\/p>\n\n\n<p>\n\n\n  For patients who have received any one of these products, clinicians are advised to stop usage immediately and observe patients for any\n\n\n  signs of new infection (e.g., fevers or chills). Clinicians are requested to report any suspected adverse events following use of these\n\n\n  products to FDA&#8217;s MedWatch program at 1-800-332-1088 or <a href=\"http:\/\/www.fda.gov\/medwatch\">www.fda.gov\/medwatch<\/a>. On May 17,\n\n\n  2010, FDA posted an announcement that Sagent Pharmaceuticals, Inc. had announced a voluntary recall of specific lots of metronidozole\n\n\n  injection (see <a href=\"http:\/\/www.fda.gov\/Safety\/Recalls\/ucm212302.htm\" title=\"http:\/\/www.fda.gov\/Safety\/Recalls\/ucm212302.htm http:\/\/www.fda.gov\/medwatch\">http:\/\/www.fda.gov\/Safety\/Recalls\/ucm212302.htm<\/a>). Today&#8217;s HAN Advisory\n\n\n  announces a recall initiated by Claris covering all lots of the three affected products (metronidazole, ciprofloxacin, and ondansetron)\n\n\n  manufactured by Claris and sold under the labels Claris, Sagent, West-Ward, and Pfizer.\n\n\n<\/p>\n\n\n<h3>\n\n\n  For More Information:\n\n\n<\/h3>\n\n\n<p>\n\n\n  FDA intends to provide new information when it becomes available. Clinicians with additional questions may contact FDA at 1-888-463-6332\n\n\n  or <a href=\"mailto:druginfo@fda.hhs.gov\" target=\"_blank\" title=\"mailto:druginfo@fda.hhs.gov\">druginfo@fda.hhs.gov<\/a>\n\n\n<\/p>\n\n\n<p>\n\n\n  Additional information is available at: <a href=\"http:\/\/www.fda.gov\" target=\"_blank\" title=\"http:\/\/www.fda.gov\/\">www.fda.gov<\/a>\n\n\n<\/p>\n\n\n<p>\n\n\n  ************************************\n\n\n<\/p>\n\n\n<p>\n\n\n  You are receiving this email because you are a registered member of the Delaware Health Alert Network. If you are not a member and would\n\n\n  like to subscribe, please register at <a href=\"https:\/\/healthalertde.org\">https:\/\/healthalertde.org<\/a>\n\n\n<\/p><!--[END]-->\n\n  \n\n        <div class=\"panel panel-danger\">\n\n          <div class=\"panel-heading\">    \n\n      <h2>Categories of Health Alert messages:<\/h2>\n\n       <\/div>\n\n       <div class=\"panel-body\">\n\n      <ul>\n\n        <li><strong>Health Alert:<\/strong> Conveys the highest level of importance; warrants immediate action or attention.<\/li>\n\n        <li><strong>Health Advisory:<\/strong> Provides important information for a specific incident or situation; may not require immediate action.<\/li>\n\n        <li><strong>Health Update:<\/strong> Provides updated information regarding an incident or situation; unlikely to require immediate action.<\/li>\n\n            <\/ul>\n\n         <div><strong>NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.<\/strong><\/div>\n\n          <\/div> \n\n        <\/div><br>  \n\n\n\n      <\/div>\n\n    <\/div>\n\n  <\/div><!-- \/container -->\n\n  <\/div>","protected":false},"excerpt":{"rendered":"<p>Listen Delaware Health Alert Network #229 June 1, 2010 11:17am Public Health Menu Home About About DPH Sections &#038; Programs Office Locations Contact Info Calendar Services A-Z Services Air &#038; Water Quality Birth, Death, &#038; Marriage Records Clinics Health Data &#038; Statistics Emergency Preparedness Health &#038; Wellness Healthy Homes Healthy Workplaces Laboratory Restaurant Inspections Screening [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":9294,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-10192","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/comments?post=10192"}],"version-history":[{"count":1,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10192\/revisions"}],"predecessor-version":[{"id":11368,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10192\/revisions\/11368"}],"up":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/9294"}],"wp:attachment":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/media?parent=10192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}