Recall of EpiPen

Recall of EpiPen

This month, the U.S. Food and Drug Administration alerted consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products, which are commonly used for emergency treatment of serious allergic reactions. The main reason for the recall is because of the possibility that these devices may contain a defective part, which may result in failure to activate.

Although the number of reported failures are minuscule, EpiPen produces which potentially contain a defective function are being recalled due to the possibility of life-threatening risk in the event of a severe allergic reaction. The 13 lots identified were distributed between December 17, 2015, and July 1, 2016, and only affect the United States.

The following is a list of the 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 requests any consumers and healthcare providers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program by either:

  • Completing and submitting the report online at www.fda.gov/medwatch/report.htm
  • Downloading and completing the form, then submitting it via fax at 800-FDA-0178.

If you suffered an injury caused by a defective medical product in Florida, contact David C. Rash P.A. today.

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