Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole

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The products have been found to have omeprazole and diclofenac. FDA laboratory analysis confirmed that Umary contains diclofenac and omeprazole", "datePublished": "Thu, 11/21/2024 - 18:42", "dateModified": "Thu, 11/21/2024 - 12:00", "author": { "@type": "Organization", "name": "Office of Regulatory Affairs" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta property="og:description" content="MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. 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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">Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole</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%2Fmxbbb-issues-voluntary-nationwide-recall-umary-acid-hyaluronic-due-presence-diclofenac-and" 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=Mxbbb%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Umary%20Acid%20Hyaluronic%20Due%20to%20the%20Presence%20of%20Diclofenac%20and%20Omeprazole&url=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fmxbbb-issues-voluntary-nationwide-recall-umary-acid-hyaluronic-due-presence-diclofenac-and" 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%2Fmxbbb-issues-voluntary-nationwide-recall-umary-acid-hyaluronic-due-presence-diclofenac-and&title=Mxbbb%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Umary%20Acid%20Hyaluronic%20Due%20to%20the%20Presence%20of%20Diclofenac%20and%20Omeprazole&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=Mxbbb%20Issues%20Voluntary%20Nationwide%20Recall%20of%20Umary%20Acid%20Hyaluronic%20Due%20to%20the%20Presence%20of%20Diclofenac%20and%20Omeprazole&body=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Fmxbbb-issues-voluntary-nationwide-recall-umary-acid-hyaluronic-due-presence-diclofenac-and" 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="2024-11-21T05:00:00Z">November 21, 2024</time> </dd> <dt class="cell-1_2">FDA Publish Date:</dt> <dd class="cell-2_2"><time datetime="2024-11-21T17:00:00Z">November 21, 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">The product contains undeclared diclofenac and omeprazole</div> </div> </dd> <dt class="cell-1_5">Company Name:</dt> <dd class="cell-2_5">MXBBB</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">Umary</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">UMARY Hyaluronic Acid tablets</div> </div> </div> </dd> </dl> </div> <hr> <h2 id="recall-announcement">Company Announcement</h2> <p>MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA did a laboratory analysis that confirmed that Umary contains diclofenac and omeprazole.</p> <p>Risk Statement: The product Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acid-related disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headaches. This hidden ingredient may mask stomach issues such as erosion, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications. MXBBB has not received any reports of adverse events related to this recall till date.</p> <p>UMARY was distributed Nationwide Via Amazon.</p> <p>The product is used as dietary supplement and is packaged in a plastic container. The affected UMARY Acid hyaluronic. UPC:7502265120323 30 caplets of 850mg include the following Lot number: 24183 and the expiration date: 07/01/28. 321 units were distributed.</p> <p>MXBBB is notifying its customers by Amazon and is arranging for the return of all recalled products. Consumers that have Umary which is being recalled should stop using/return to place of purchase for a full refund. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.</p> <p>Consumers with questions regarding this recall can contact MXBBB by email <a href="mailto:Joshua980810@outlook.com">Joshua980810@outlook.com</a> seven days a week, 24-hours a day.</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>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>Joshua Montoya</dd> <dd><span class="fa fa-phone" aria-hidden="true"></span> 915-258-6936</dd> <dd><span class="fa fa-envelope" aria-hidden="true"></span><a href="mailto:Joshua980810@outlook.com"> Joshua980810@outlook.com</a></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/picture1_3.jpg?itok=fAk0-iiG 203w" media="all and (max-width: 320px)" type="image/jpeg" sizes="100vw" width="203" height="203"/> <source srcset="/files/styles/recall_image_small/public/picture1_3.jpg?itok=fAk0-iiG 203w" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" sizes="100vw" width="203" height="203"/> <source srcset="/files/styles/recall_image_large/public/picture1_3.jpg?itok=2uuRnau6 1020w" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" sizes="100vw" width="1020" height="1020"/> <source srcset="/files/styles/recall_image_large/public/picture1_3.jpg?itok=2uuRnau6 1020w" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" sizes="100vw" width="1020" height="1020"/> <source srcset="/files/styles/recall_image_large/public/picture1_3.jpg?itok=2uuRnau6 1020w" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" sizes="100vw" width="1020" height="1020"/> <source srcset="/files/styles/recall_image_large/public/picture1_3.jpg?itok=2uuRnau6 1020w" media="all and (min-width: 1201px)" type="image/jpeg" sizes="100vw" width="1020" height="1020"/> <img loading="eager" src="/files/styles/recall_image_small/public/picture1_3.jpg?itok=fAk0-iiG" width="203" height="203" alt="UMARY Acido Hialuronico, dietary supplement, 30 caplets" 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 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Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole | FDA