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EpiPen Defective - Recall

EpiPen Defective - Recall

Last month, the U.S. Food and Drug Administration (FDA) alerted consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr Auto-Injector products used for emergency treatment of serious allergic reactions. The recall has been administered due to the possibility that these devices may have a defect that leads to the devices’ failure to activate.

Although the number of reported failures is minimal, EpiPen devices which potentially contain a defective part are being recalled due to the potential for life-threatening risk if a serious allergic reaction is left untreated. Distributed between December 17, 2015 and July 1, 2015, the 13 lots identified are the only EpiPen lots affected by the U.S. recall. Those who have EpiPens from lots that are not included in this recall do not need to replace their EpiPen.

Here is the list of U.S. impacted lots:

Product/Dosage

NDC Number on Carton

Lot Number

Expiration Date

EpiPen Jr. 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

5GN767

April 2017

EpiPen Jr. 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

5GN773

April 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

5GM631

April 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

5GM640

May 2017

EpiPen Jr. 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

6GN215

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM082

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM072

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM081

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM088

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM199

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM091

October 2017

The FDA asks medical professional and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program by reporting it online at www.fda.gov/medwatch/report.htm.

If you suffered an injury caused by a defective medical device or product, contact our Louisville medical malpractice attorney at Brett H. Oppenheimer, PLLC today.

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