FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen

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CGMP violations associated with the manufacture of EpiPen</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/drugs/drug-safety-and-availability" title="Drug Safety and Availability"> Drug Safety and Availability </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-2" 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">FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a 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The warning letter identifies significant violations of current good manufacturing practice (CGMP) requirements for its epinephrine auto injectors, including EpiPen and EpiPen Jr, and instructs the company to undertake steps to correct those violations. FDA understands the importance of epinephrine auto-injectors and will work to ensure that the company鈥檚 corrections are adequate so that patients can be assured of the safety and efficacy of the products.</p> <p>FDA is not aware of defective EpiPens currently on the market and recommends that consumers use their prescribed epinephrine auto injector. As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens.</p> <p>FDA asks health care professionals and consumers to report any adverse reactions or quality problems to the FDA鈥檚 <a href="/medwatch-fda-safety-information-and-adverse-event-reporting-program">MedWatch</a> program:</p> <ul type="disc"> <li>Complete and submit the report online at <a href="http://www.fda.gov/medwatch/report.htm" target="_blank">www.fda.gov/medwatch/report.htm</a>.</li> <li>Download and complete the <a href="/download-forms">form</a>, then submit it via fax at 1-800-FDA-0178.</li> </ul>   </div> 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FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen | FDA