Multistate outbreak of fungal meningitis and other infections

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</li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-14" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Multistate outbreak of fungal meningitis and other infections</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fdrugs%2Fdrug-safety-and-availability%2Fmultistate-outbreak-fungal-meningitis-and-other-infections" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Multistate%20outbreak%20of%20fungal%20meningitis%20and%20other%20infections&url=https://www.fda.gov%2Fdrugs%2Fdrug-safety-and-availability%2Fmultistate-outbreak-fungal-meningitis-and-other-infections" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fdrugs%2Fdrug-safety-and-availability%2Fmultistate-outbreak-fungal-meningitis-and-other-infections&title=Multistate%20outbreak%20of%20fungal%20meningitis%20and%20other%20infections&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Multistate%20outbreak%20of%20fungal%20meningitis%20and%20other%20infections&body=https://www.fda.gov%2Fdrugs%2Fdrug-safety-and-availability%2Fmultistate-outbreak-fungal-meningitis-and-other-infections" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p><strong>Laboratory Testing and Results</strong></p> <p><strong>[12-12-2012] </strong>FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as <em>Bacillus</em>, and fungal species including <em>Aspergillus tubingensis,  Aspergillus fumigatus,  Cladosporium </em>species,and<em> Penicillium </em>species.  Although rare, some of the identified <em>Bacillus</em> species can be human pathogens.  Some of the fungal organisms identified, particularly <em>Aspergillus fumigatus</em>, are known to cause disease in humans.  It is not known how product contamination with these organisms could affect patients clinically. See <a href="https://www.cdc.gov/medication-safety/about/index.html?CDC_AAref_Val=https://www.cdc.gov/medicationsafety/recalls/necc/#advice">CDC’s Advice for Clinicians</a>.</p> <h4 style="text-align: center"><strong>CDC and FDA Laboratory-Confirmed Organisms from Product Samples </strong></h4> <p style="text-align: center"><strong>Laboratory-Confirmed Organisms from Product Samples Associated with<br> NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions</strong></p> <div class="table-responsive"> <table border="1" cellpadding="0" cellspacing="0" class="table table-bordered table-striped" summary=" " width="100%"> <tbody> <tr> <th scope="col">Medication</th> <th scope="col">Lot Number</th> <th scope="col">Bacterial and Fungal Contamination</th> </tr> <tr> <td scope="row">Betamethasone<br> 6 mg/mL injectable –5 mL per vial</td> <td>08202012@141</td> <td><em>Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus</em> sp., <em>Bacillus niacini, Kocuria rosea,<br> Bacillus lentus</em></td> </tr> <tr> <td scope="row">Betamethasone<br> 6 mg/mL injectable –5 mL per vial</td> <td>07032012@22</td> <td><em>Bacillus niabensis, Bacillus circulans</em></td> </tr> <tr> <td scope="row">Betamethasone<br> 12 mg/mL injectable – 5 mL per vial</td> <td>07302012@52</td> <td><em>Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis</em></td> </tr> <tr> <td scope="row">Betamethasone<br> 6mg/mL injectable – 5 mL per vial</td> <td>08202012@44</td> <td><em>Bacillus lentus, Bacillus firmus, Bacillus pumilus</em></td> </tr> <tr> <td scope="row">Betamethasone<br> 6 mg/mL injectable – 5 mL per vial</td> <td>08152012@84</td> <td><em>Penicillium </em>sp<em>.,</em> <em>Cladosporium </em>sp.</td> </tr> <tr> <td scope="row"><br clear="all"> Triamcinolone<br> 40mg/mL injectable – 1 mL per vial</td> <td>06062012@6</td> <td><em>Bacillus lentus, Bacillus circulans, Bacillus niabensis, Bacillus nealsonii, Bacillus subtilis group, Bacillus firmus</em></td> </tr> <tr> <td scope="row">Triamcinolone<br> 40 mg/mL injectable – 2 mL per vial</td> <td>08172012@60</td> <td><em>Aspergillus tubingensis,</em> <em>Penicillium </em>sp.</td> </tr> <tr> <td scope="row">Triamcinolone<br> 40mg/mL injectable – 10 mL per vial</td> <td>08242012@2</td> <td><em>Aspergillus fumigatus </em></td> </tr> <tr> <td scope="row">Cardioplegia solution<br> 265.5 mL per bag</td> <td>09242012@55</td> <td><em>Bacillus halmapalus/horikoshii, Brevibacillus choshinensis</em></td> </tr> </tbody> </table> </div> <p> </p> <h2>Related Information</h2> <ul> <li><a href="/media/84684/download">FDA Form 483 for New England Compounding Center</a></li> <li><a href="/drugs/drug-shortages/meningitis-outbreak-voriconazole-and-liposomal-amphotericin-b-availability-information">Meningitis Outbreak: Voriconazole IV availability information</a></li> </ul> <h2>Resources</h2> <ul> <li><a href="/media/84102/download">Patient Notification Letter</a></li> <li><a href="http://blogs.fda.gov/fdavoice/index.php/2012/11/were-working-to-offset-ameridose-impact/" target="_blank">FDA Voice: We're Working to Offset Ameridose Impact</a></li> <li><a href="http://blogs.fda.gov/fdavoice/index.php/2012/10/state-and-local-partnerships-are-crucial/" target="_blank">FDA Voice: State and Local Partnerships Are Crucial</a></li> </ul> <h2>NECC Information</h2> <ul> <li><a href="/media/84516/download">New England Compounding Center (NECC) Customer List Since 5/21/2012, Sorted by State - No Product Information</a></li> <li><a href="/media/84508/download">New England Compounding Center (NECC) Customer List Since 5/21/2012, Sorted by Customer - With Product Information</a></li> </ul> <h2>CDC Information</h2> <ul> <li><a href="https://archive.cdc.gov/#/details?url=https://www.cdc.gov/hai/outbreaks/infographic.html" target="_blank">Fungal Meningitis Outbreak Infographic (CDC)</a></li> <li><a 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Multistate outbreak of fungal meningitis and other infections | FDA