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Dangerous Drugs & Medical Devices

A Nationwide Voluntary Recall was issued for EpiPen and EpiPen, Jr. on March 31, 2017.

A Nationwide Voluntary Recall was issued for EpiPen and EpiPen, Jr. on March 31, 2017.

EpipenOn March 31, 2017, the U.S. Food and Drug Administration (FDA) announced a Nationwide Voluntary Recall had been issued for EpiPen and EpiPen, Jr.

The Nationwide Voluntary Recall was issued by the drugs manufacturer MYLAN, due to a potential defect that could cause the device to be infective, leading to a failure that would prevent the appropriate delivery of the lifesaving medication to a patient that is having a severe allergic reaction.

The failure of an EpiPen or EpiPen, Jr. as described in the recall could result in serious injury or death for a patient having a severe allergic reaction.

This current recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of the device failing to activate due to a potential defect in a supplier component. 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).
Both reports are related to the single lot that was previously recalled.

The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

EpiPen or EpiPen, Jr., are devices that deliver a dose of the lifesaving medication, epinephrine to patients experiencing a severe allergic reaction. In September 2017, the FDA sent a letter to the manufacturing facility that Mylan utilizes to produce the EpiPen or EpiPen, Jr., expressing a number of concerns, with the most alarming being that after receiving “hundreds of complaints” the company failed to investigate the potential for a deadly defect in the product.

Furthermore, the letter questions why, after defective devices were linked to patient deaths the company took no actions to investigate or correct issues related to the potential for failure of the devices until the FDA began investigations.

In addition to this Nationwide Voluntary Recall, Mylan issued another recall of EpiPens earlier this year. That recall impacted more than 20 lots of EpiPens. Mylan has also come under fire for increasing the price of the EpiPen. The price for the EpiPen has increased more than 400% in recent years. The company has also been investigated by the U.S. Justice Department for overcharging the government that ended with Mylan entering into a $465 million settlement with the agency.

For many, this has caused great concerns related to the safety and effectiveness of the products. If you are one of the thousands of people that have been prescribed or that stock EpiPen or EpiPen, Jr. in your emergency medical kit, please check the recalled lot information listed below.

If you or your family member has had an issue when using an EpiPen or EpiPen, Jr., that may have caused further health complications, it is important to report those issues to the FDA.

If you or a family member used an EpiPen or EpiPen, Jr., and experienced a failure of the device to function properly, resulting in additional health complications or death, those claims should be investigated. The attorneys at Wallace & Graham, P.A. are here to assist you, and investigate your claim.
For help investigating potential claims related to defective with an EpiPen or EpiPen, Jr., please contact our office at 1-800-849-5291.

FDA Information on the EpiPen or EpiPen, Jr. Nationwide Voluntary Recall

According to information posted on the FDA website, as of March 31, 2017, the recall effects 13 lots. 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.
Product/Dosage                                                  NDC Number         Lot Number                       Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg                49502-501-02                  5GN767                             April 2017
EpiPen Jr Auto-Injector, 0.15 mg                49502-501-02                  5GN773                             April 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  5GM631                            April 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  5GM640                            May 2017
EpiPen Jr Auto-Injector, 0.15 mg                49502-501-02                  6GN215                             September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM082                            September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM072                            September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM081                            September 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM088                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM199                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM091                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM198                            October 2017
EpiPen Auto-Injector, 0.3 mg                      49502-500-02                  6GM087                            October 2017

To review FDA RECALL INFORMATION, click here.

SOURCES
EpiPen® Voluntary Recall Website    https://www.epipen.com/recall-information

FDA News Release FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm550170.htm

FDA Company Announcement, March 31, 2017; Mylan Provides Update on Meridian Medical Technologies’, a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector https://www.fda.gov/safety/recalls/ucm550173.htm

FDA News Release, March 31, 2017; FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm550170.htm

FDA Letter, Dated: September 5, 2017 to Meridian Medical Technologies, Inc. a Pfizer Company https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm

Withdrawals, & Safety Alerts Website: https://www.fda.gov/safety/recalls/

How Consumers Can Report an Adverse Event or Serious Problem to FDA https://www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm

EpiPen cost soars, but it’s not the only drug to http://www.cnn.com/2016/08/23/health/epipen-price-mylan-prescription-drugs-increase/index.html
Mylan Wraps Up $465 Million U.S. Accord Over EpiPen Rebates https://www.bloomberg.com/news/articles/2017-08-17/mylan-agrees-to-465-million-settlement-of-u-s-epipen-claims

Photo credit CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=1193843

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