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March 31, 2017

EpiPen Auto-Injector Recall Facts

Philadelphia, PA – March 31, 2017 – UPDATE: FDA announces nationwide recall of EpiPen® and EpiPen®JR. If you have been prescribed an adrenaline auto-injector, The Asthma Center advises you to check the lot number and expiration date.

 

According to the 3/29/2017  FDA announcement, at this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. 

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 April 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

What to do:

  • If you have a 0.15 mg EpiPen®  Jr or 0.3 mg EpiPen® , check the lot number and expiration which are found on the label of the pen or on the end of the carton.
  • If your 0.15 mg EpiPen®  Jr or 0.3 mg EpiPen®  matches any of the lot numbers/expirations above,  return it immediately to your pharmacist.  Your pharmacist will replace it FREE OF CHARGE.

     

 

 

Philadelphia, PA – March 29, 2017 – “According to the makers of EpiPen®, the recalled EpiPen® 300 µg Auto-Injectors were not distributed in the United States.  However, if you have been prescribed an adrenaline auto-injector, we still advise you to check the lot number and expiration date.”

Dr. Marc Goldstein, Board-Certified Allergist at The Asthma Center

 

EpiPen Recall Facts

  • EpiPen®Adrenaline Injection Auto-Injector is used to treatment of allergic emergencies (Anaphylaxis).
  • Mylan-owned Alphapharm Pty Ltd, following consultation with the Therapeutic Goods Administration, is recalling the following batches of EpiPen®300 microgram (µg) Adrenaline Injection Syringe Auto-Injectors due to the potential that these devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate. 

EpiPen® 300 microgram (µg) Adrenaline Injection Syringe Auto-Injector

Batch Number(s) 5FA665, 5FA6651, 5FA6652, 5FA6653

Expiration: Apr 17

  • Devices included in the recall were distributed in Australia, New Zealand, Japan and a variety of European countries including Denmark, Norway, Finland and Ireland, but not in the United States.
  • If you have a 300 microgram (µg) EpiPen® , check the batch number and expiration which are found on the label of the pen or on the end of the carton.

If your EpiPen®   300 microgram (µg) matches the batch numbers 5FA665, 5FA6651, 5FA6652, 5FA6653 and has an expiration of Apr 17, return it immediately to your pharmacist.  Your pharmacist will replace it FREE OF CHARGE.

 

Anaphylaxis: The Most Serious Allergic Reaction

Allergists recognize that the anaphylaxis (a life-threatening allergic emergency) can have multiple causes such as allergic sensitivity to foods, drugs, insect sting, and exercise.   Evaluation for risk of anaphylaxis extensive history, physical examination, and specific diagnostic tests to identify all possible causes.  Our allergists and pediatric allergists at The Asthma Center are well suited to evaluate individuals with anaphylaxis.

The Asthma Center allergists and pediatric allergists can make a potentially life-saving difference if you (or someone you love) are at risk for anaphylaxis.

Our allergists, pediatric allergists, and asthma specialists treat patients in 9 convenient locations throughout the Delaware Valley including Philadelphia (Center City Philadelphia, Society Hill Philadelphia, Northeast Philadelphia), The Main Line – Montgomery County (Bala Cynwyd – Lower Merion PA), Bucks County (Langhorne PA), and South Jersey (Mt. Laurel NJ, Woodbury NJ, Hamilton NJ, Forked River NJ).

 

The health information contained in this article is meant for basic informational purposes only.  It is not intended to serve as medical advice, substitute for a doctor’s appointment or to be used for diagnosing or treating a disease.

For interviews and tours of the Delaware Valley’s only National Allergy Bureau (NAB) certified pollen, ragweed, and mold spore counting stations in Philadelphia, PA and Mt. Laurel, NJ, please email gwoodlyn@asthmacenter.com.

 

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The allergists and asthma doctors at The Asthma Center strive to provide the best allergy, asthma, immunology, and sinus care to patients using the latest diagnostic tools and treatment strategies. Our allergists are focused on fostering strong communication with patients and improving quality of life. We have decades of medical experience treating patients, and our allergists are recognized as Top Doctors and Super Doctors. Taking care of our patients is our top priority!