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Recall of EpiPen

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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 Weston, contact Rash Mueller. today.

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