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EpiPen Products Recalled Over Device Failure

Apr 3, 2017

EpiPen and Pediatric EpiPen Jr. Recalled Due to Defective Part

Mylan's EpiPen Products Recalled Over Device Failure

The U.S. Food and Drug Administration (FDA) recently issued an alert to consumers regarding Meridian Medical Technologies' voluntary recall of 13 lots of Mylan's EpiPen and EpiPen Jr. (epinephrine injection) Auto-Injector products that are prescribed for the emergency treatment of severe allergic reactions, including anaphylaxis and severe asthma attacks.

Anaphylaxis is a severe allergic reaction that requires immediate treatment, according to WebMD. An anaphylactic reaction calls for an epinephrine (adrenaline) shot as soon as possible, as well as calling 911 for emergency medical help. Left untreated, anaphylaxis may be deadly; however, epinephrine usually reverses the symptoms within minutes. If this does not occur, a second shot within half an hour may be needed. The shots require a prescription and come pre-filled and in ready-to-use pens, according to WebMD.

The symptoms of anaphylaxis include coughing, wheezing, pain, itching, tightness in the chest and/or throat, fainting, dizziness, confusion, weakness, hives, rash, itchy and/or swollen or red skin, runny or stuffy nose, sneezing, shortness of breath, trouble breathing, rapid heartbeat, swollen or itchy mouth or throat, hoarse voice, trouble swallowing, vomiting, diarrhea, cramps, weak pulse, and paleness. Some patients report a "sense of doom" or panic prior to the attack, WebMD notes.

According to the FDA, the recall was implemented over the potential that these devices may contain a defective part that may cause the devices to fail to activate. Specifically, EpiPen and EpiPen Jr. are manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

The recalled EpiPen and EpiPen Jr. products potentially contain a defective part and the possibility that a life-threatening risk will occur if a severe allergic reaction remains untreated. Federal regulators recommend that consumers keep and use their current EpiPens, if needed, until they receive a replacement. Note that the product label indicates that consumers should always seek emergency medical help immediately following EpiPen use, especially if the device did not activate.

Of the 13 lots identified, the EpiPen and EpiPen Jr. products were distributed between December 17, 2015 and July 1, 2016. These are the only EpiPen lots impacted by the United States recall. Consumers in possession of EpiPen products from lots that are not included in this recall have no need to replace their EpiPen prior to its expiration date. For a complete list of product/dosage, NDC number, lot number, and expiration, see the FDA's website for details:

Mylar suggests that if a consumer has a product affected by this recall to adhere to the following:

  • Check the lot number on the carton or device to determine if the EpiPen® Auto-Injector is included by the recall.
  • If the EpiPen® Auto-Injector has been recalled, contact Stericycle at 877-650-3494 to obtain a voucher code for a free replacement product. Stericycle also will provide a pre-paid return package to ship the product back to Stericycle.
  • Visit your pharmacy with your voucher information to redeem the free replacement.
  • Send the recalled product to Stericycle. Do not return any recalled devices until the replacement device is received.

USA Today points out that Meridian Medical Technologies is a Pfizer company. The nationwide recall includes both life-saving devices, the EpiPen and the children's version, the EpiPen Jr.

"The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis)," the device maker indicated in a statement.

The company recalled the EpiPen product in several countries in February 2017 after it received two reports of the EpiPen device failing to activate, according to USA Today. Only one lot was found to be defective; however 13 lots were recalled from the U.S. market as a precaution. The current recall will extend to Europe, Asia, North America, and South America, according to Mylan. The recall incudes the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector distributed between December 2015 and July 2016. Mylan will replace the EpiPens at no cost. Customers may reach the company directly for updates on product return and replacement instructions.

NPR noted that the recent announcement followed a much larger recall of some 80,000 EpiPens from the Australian market, which the company announced in March. Mylan did not immediately respond to NPR's request for information about how many EpiPens are affected by the latest recall.

Epinephrine auto-injectors-known under the brands, EpiPen and EpiPen Jr.-are easy to carry and easy to use devices that are critical for anyone who suffers from serious allergies, NPR reported. Meanwhile, the FDA is instructing consumers to keep and use the recalled auto-injectors until their replacements arrive, even if they are in possession of an EpiPen or an EpiPen Jr. that is included in the recall.

Parker Waichman LLP has spent decades representing clients in drug and medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing an EpiPen or EpiPen Jr. lawsuit.

EpiPen Prices Continue to Sharply Rise

EpiPen Prices Continue to Sharply Rise

The price of the EpiPen has increased just about five-fold in the past decade. In 2007, EpiPens were available for $47. NPR's Alison Kodjak reported in 2016 that the price of EpiPens jumped to $284. Because the EpiPen auto-injectors were only available in pairs, the cost to fill an EpiPen prescription at Walgreens, as of August 2016, was, for many, a prohibitive $634. According to the GoodRX, the average retail price of a pair of EpiPens now runs $330.

After significant criticism over the sharp price increase, in December 2016 Mylan introduced a generic EpiPen at $300, which was half the price of the brand name alternative. Mylan also previously offered coupons to reduce out-of-pocket EpiPen costs. NPR notes that the generic EpiPens, which are also manufactured by Meridian Medical Technologies, are not included in this recent recall.

In 2016, the Centers for Medicare and Medicaid Services accused Mylan of misclassifying EpiPens and over-charging the government for Medicaid patients who used EpiPen and EpiPen Jr. Mylan settled for $465 million with the U.S. Justice Department and other government agencies.

In 2015, another epinephrine auto-injector was pulled from the market by EpiPen competitor Auvi-Q. The Auvi-Q was removed from shelves after it was found to deliver an unreliable dose of epinephrine, noted NPR. Auvi-Q is available again, and its maker, privately-held drug maker Kaleo Pharmaceuticals, has indicated that all commercially insured patients may pay nothing out-of-pocket for the auto-injector.

Filing an Insulin Lawsuit

If you or someone you know is interested in filing a personal injury lawsuit involving EpiPen or EpiPen Jr., contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

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