Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

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Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/safety/recalls-market-withdrawals-safety-alerts" title="Recalls, Market Withdrawals, & Safety Alerts"> Recalls, Market Withdrawals, & Safety Alerts </a> </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-7" 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"> <p class="content-type-label text-center">COMPANY ANNOUNCEMENT</p> <h1 class="content-title text-center">Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination</h1> <div class="alert alert-danger text-center col-xs-12" id="disclaimer"> <p>When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.</p> <a class="btn btn-default" href="#recall-announcement">Read Announcement</a> <a class="btn btn-default" href="#recall-photos">View Product Photos</a> </div> <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%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial" 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=Bionpharma%20Inc.%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Atovaquone%20Oral%20Suspension%20Due%20to%20Bacterial%20Contamination&url=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial" 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%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial&title=Bionpharma%20Inc.%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Atovaquone%20Oral%20Suspension%20Due%20to%20Bacterial%20Contamination&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=Bionpharma%20Inc.%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Atovaquone%20Oral%20Suspension%20Due%20to%20Bacterial%20Contamination&body=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fbionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial" 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"> <h2>Summary</h2> <div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">Company Announcement Date:</dt> <dd class="cell-2_1"><time datetime="2024-09-17T17:23:00Z">September 17, 2024</time> </dd> <dt class="cell-1_2">FDA Publish Date:</dt> <dd class="cell-2_2"><time datetime="2024-09-18T04:00:00Z">September 18, 2024</time> </dd> <dt class="cell-1_3">Product Type:</dt> <dd class="cell-2_3">Drugs </dd> <dt class="cell-1_4">Reason for Announcement:</dt> <dd class="cell-2_4"> <div class="field field--name-field-recall-reason-description field--type-string field--label-above"> <div class="field--label">Recall Reason Description</div> <div class="field--item">Product found to be contaminated with Cohnella bacteria</div> </div> </dd> <dt class="cell-1_5">Company Name:</dt> <dd class="cell-2_5">Bionpharma Inc.</dd> <dt class="cell-1_6">Brand Name:</dt> <dd class="cell-2_6"> <div class="field field--name-field-brand-name field--type-entity-reference field--label-inline"> <div class="field--label">Brand Name(s)</div> <div class="field--items"> <div class="field--item">BionPharma</div> </div> </div> </dd> <dt class="cell-1_7">Product Description:</dt> <dd class="cell-2_7"> <div class="field field--name-field-product-description field--type-string field--label-above"> <div class="field--label">Product Description</div> <div class="field--items"> <div class="field--item">Atovaquone Oral Suspension, 750 mg/mL</div> </div> </div> </dd> </dl> </div> <hr> <h2 id="recall-announcement">Company Announcement</h2> <p>FOR IMMEDIATE RELEASE – September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.</p> <p>Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.</p> <p>We take these findings seriously and are taking immediate action to address the situation. We have initiated a recall of the (1) affected batch listed below and are implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process.</p> <p>This product is a quinone antimicrobial drug indicated for prevention of pneumocycstis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older. The affected batch of product was manufactured at CoreRx, Inc. and shipped nationwide to our customers between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers. The recall includes the following product and batch number:</p> <div class="inset-column"> <table class="table table-bordered table-striped table-condensed"> <thead> <tr> <th scope="col"> <p align="center"><strong>Production Date </strong></p> </th> <th scope="col"> <p align="center"><strong>Release Date </strong></p> </th> <th scope="col"> <p align="center"><strong>Product Name </strong></p> </th> <th scope="col"> <p align="center"><strong>NDC </strong></p> </th> <th scope="col"> <p align="center"><strong>Lot No.</strong></p> </th> <th scope="col"> <p align="center"><strong>Expiration Date </strong></p> </th> </tr> </thead> <tbody> <tr> <td class="text-align-center">October 26, 2023</td> <td class="text-align-center">December 05, 2023</td> <td class="text-align-center">Atovaquone Oral Suspension</td> <td class="text-align-center">69452-252-87</td> <td class="text-align-center">2310083</td> <td class="text-align-center">September 2025</td> </tr> </tbody> </table> </div> <p>The product can be identified by the HDPE white bottle, picture below.</p> <p>The lot number can be obtained from the side panel of the bottle or the bottom flap of the carton.</p> <p>The Company is notifying its distributors and customers by email and is arranging for return/replacement etc. of the recalled batch of the product. Distributors/retailers that have affected lot of the drug product which is being recalled should immediately cease distribution and remove it from active inventory. Consumers that have the affected lot of the product should stop using the product and return to the place of purchase</p> <p>Consumers with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST) or via email to <a href="mailto:drugsafety@bionpharma.com">drugsafety@bionpharma.com</a>. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the affected lot of the drug product</p> <p>Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.</p> <ul> <li>Complete and submit the report <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="30cfb1be-3244-4fd7-a804-9647e3551562" href="/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda" title="Reporting Serious Problems to FDA">Online</a></li> <li>Regular Mail or Fax: <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="cbd5f29e-012d-4a51-b896-ee98e5cbac62" href="/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting" title="MedWatch Forms for FDA Safety Reporting">Download form</a> or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178</li> </ul> <p>Reporting to Company:</p> <ul> <li>Via phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST)</li> <li>Via email to <a href="mailto:drugsafety@bionpharma.com">drugsafety@bionpharma.com</a></li> </ul> <p>This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.</p> <div class="inset-column"> <hr> <h2>Company Contact Information</h2> <div class="row"> <div class="col-xs-12 col-md-6"> <dl> <dt>Consumers:</dt> <dd>Drug Safety Department, Bionpharma Inc.</dd> <dd><span class="fa fa-phone" aria-hidden="true"></span> 1-888-235-2466</dd> </dl> </div> <div class="col-xs-12 col-md-6"> <dl> </dl> </div> </div> </div> <hr> <div id="recall-photos" class="recall-photos lazy-load"> <h2>Product Photos</h2> <ul class="list-unstyled nav-stacked"> <li> <figure> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/recall_image_small/public/image_1_83.jpg?itok=qwRFhFCL 455w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="455" height="606"/> <source srcset="/files/styles/recall_image_small/public/image_1_83.jpg?itok=qwRFhFCL 455w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="455" height="606"/> <source srcset="/files/styles/recall_image_large/public/image_1_83.jpg?itok=4Io9xhHm 1020w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="1020" height="1359"/> <source srcset="/files/styles/recall_image_large/public/image_1_83.jpg?itok=4Io9xhHm 1020w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="1020" height="1359"/> <source srcset="/files/styles/recall_image_large/public/image_1_83.jpg?itok=4Io9xhHm 1020w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="1020" height="1359"/> <source srcset="/files/styles/recall_image_large/public/image_1_83.jpg?itok=4Io9xhHm 1020w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="1020" height="1359"/> <img loading="eager" src="/files/styles/recall_image_small/public/image_1_83.jpg?itok=qwRFhFCL" width="455" height="606" alt="Front of bottle, BionPharma Atovaquone Oral Suspension" class="img-responsive" /> </picture> </div> </div> </figure> </li> <li> <figure> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/recall_image_small/public/image_2_68.jpg?itok=RMFJENy7 458w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="458" height="611"/> <source srcset="/files/styles/recall_image_small/public/image_2_68.jpg?itok=RMFJENy7 458w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="458" height="611"/> <source srcset="/files/styles/recall_image_large/public/image_2_68.jpg?itok=w5CdsWUb 1020w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="1020" height="1361"/> <source srcset="/files/styles/recall_image_large/public/image_2_68.jpg?itok=w5CdsWUb 1020w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="1020" height="1361"/> <source srcset="/files/styles/recall_image_large/public/image_2_68.jpg?itok=w5CdsWUb 1020w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="1020" height="1361"/> <source srcset="/files/styles/recall_image_large/public/image_2_68.jpg?itok=w5CdsWUb 1020w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="1020" height="1361"/> <img loading="eager" src="/files/styles/recall_image_small/public/image_2_68.jpg?itok=RMFJENy7" width="458" height="611" alt="Back of bottle, BionPharma Atovaquone Oral Suspension" class="img-responsive" /> </picture> </div> </div> </figure> </li> <li> <figure> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/recall_image_small/public/image_3_35.jpg?itok=3OA4RlMD 346w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="346" height="614"/> <source srcset="/files/styles/recall_image_small/public/image_3_35.jpg?itok=3OA4RlMD 346w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="346" height="614"/> <source srcset="/files/styles/recall_image_large/public/image_3_35.jpg?itok=pbDqT0qp 1020w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="1020" height="1810"/> <source srcset="/files/styles/recall_image_large/public/image_3_35.jpg?itok=pbDqT0qp 1020w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="1020" height="1810"/> <source srcset="/files/styles/recall_image_large/public/image_3_35.jpg?itok=pbDqT0qp 1020w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="1020" height="1810"/> <source srcset="/files/styles/recall_image_large/public/image_3_35.jpg?itok=pbDqT0qp 1020w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="1020" height="1810"/> <img loading="eager" src="/files/styles/recall_image_small/public/image_3_35.jpg?itok=3OA4RlMD" width="346" height="614" alt="Front of package, BionPharma Atovaquone Oral Suspension" class="img-responsive" /> </picture> </div> </div> </figure> </li> <li> <figure> <div> <div class="field field--name-image field--type-image field--label-hidden field--item"> <picture> <source srcset="/files/styles/recall_image_small/public/image_4_8.png?itok=2TLuaJRp 480w" media="all and (max-width: 320px)" type="image/png" sizes="100vw" width="480" height="641"/> <source srcset="/files/styles/recall_image_small/public/image_4_8.png?itok=2TLuaJRp 480w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/png" sizes="100vw" width="480" height="641"/> <source srcset="/files/styles/recall_image_large/public/image_4_8.png?itok=iW33FdBF 1020w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/png" sizes="100vw" width="1020" height="1363"/> <source srcset="/files/styles/recall_image_large/public/image_4_8.png?itok=iW33FdBF 1020w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/png" sizes="100vw" width="1020" height="1363"/> <source srcset="/files/styles/recall_image_large/public/image_4_8.png?itok=iW33FdBF 1020w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/png" sizes="100vw" width="1020" height="1363"/> <source srcset="/files/styles/recall_image_large/public/image_4_8.png?itok=iW33FdBF 1020w" media="all and (min-width: 1201px)" type="image/png" sizes="100vw" width="1020" height="1363"/> <img loading="eager" src="/files/styles/recall_image_small/public/image_4_8.png?itok=2TLuaJRp" width="480" height="641" alt="Back of package, BionPharma Atovaquone Oral Suspension" class="img-responsive" /> </picture> </div> </div> </figure> </li> </ul> </div>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-09-18T00:00:00Z">09/18/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 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Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination | FDA