EpiPen and EpiPen Jr auto-injector recall

Mylan The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies' voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date. Visit Mylan.com/EpiPenRecall for a complete list of recalled items, and replacement instructions.
Senator Amy Klobuchar, a national leader in the effort to bring down the costs of prescription drugs, raised concerns on EpiPen and called for investigations last year that resulted in Mylan agreeing to pay $465 million to resolve claims that it had misclassified EpiPen to lower the rebates it owed the government.
In August 2016, Klobuchar wrote to the Centers for Medicare and Medicaid Services (CMS) to call on the agency to provide information on the effect of Mylan’s price increases on government prescription drug costs, asking specifically why EpiPen was classified as a generic drug under the Medicaid Drug Rebate Program. Following these efforts, CMS found that Mylan had misclassified the EpiPen as a “non-innovator multiple source drug,” or generic drug, resulting in overpayment for the drug by states and the federal government through the Medicaid Drug Rebate Program. Klobuchar has also urged the Department of Health and Human Services to conduct a nationwide investigation to see how many other drugs are also misclassified. Klobuchar then called on the Department of Justice to consider investigating whether Mylan Pharmaceuticals violated the law by misclassifying EpiPen product in order to pay a lower rebate to states and reap huge profits at the expense of taxpayers.
In November, Klobuchar called on Mylan to reimburse the Department of Defense (DoD) for past overpayments for the EpiPen Auto-Injector. Mylan’s misclassification of the EpiPen as a “non-innovator multiple source drug” led the DoD to pay exorbitant rates for the drug at retail pharmacies. She has also called on the Food and Drug Administration (FDA) to answer questions about its approval process and other steps for alternatives to the EpiPen.
"I am concerned that while Mylan tried to justify hiking the price of EpiPens by pointing to quality and safety standards, it was producing flawed devices that may not work when people need them most. I will be asking Mylan to provide more information on the recall. Consumers deserve answers,” Klobuchar said.
Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions on the recall. As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate. The FDA also asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by completing and submitting the report online at www.fda.gov/medwatch/report.htm, or downloading and completing the form then submitting it via fax at 800-FDA-0178. 

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