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New EpiPen Recall Includes the US and EpiPen Jr. — What You Need to Know

On the heels of last week’s recall in seven countries for the EpiPen, Mylan has issued a new recall which not only includes EpiPens sold in the US, but also involves the children’s version, known as EpiPen Jr.

Here’s what you need to know:

  1. The EpiPens affected by the new recall were distributed between December 2015 and July 2016; however, Mylan has not yet made clear precisely how many EpiPens are affected.
  2. Mylan’s new generic EpiPen is not part of the voluntary recall and has been deemed a suitable replacement for the potentially defective product.
  3. Last week’s recall of EpiPens in countries such as Norway, Denmark, Japan, and Australia was a direct response to complaints from two consumers whose EpiPens failed to work during their allergic reactions. (Thankfully, both were able to receive medical attention and survived.)
  4. Visit Mylan.com/EpiPenRecall for replacement instructions
  5. Keep EpiPens handy even if a replacement isn’t readily available, urges Mylan.

The list of EpiPens recalled in the US can be found below:

  • EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg – Lot number: 5GN767 – Expiration: April 2017
  • EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg – Lot number: 5GN773 – Expiration: April 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 5GM631 – Expiration: April 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 5GM640 – Expiration: May 2017
  • EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg – Lot number: 6GN215 – Expiration: September 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 6GM082 – Expiration: September 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 6GM072 – Expiration: September 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 6GM081 – Expiration: September 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 6GM088 – Expiration: October 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 6GM199 – Expiration: October 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 6GM091 – Expiration: October 2017
  • EpiPen 2-Pak® Auto-Injectors, 0.3 mg – Lot number: 6GM198 – Expiration: October 2017
  • EpiPen 2-pak® Auto-Injectors, 0.3 mg – Lot number: 6GM087 -Expiration: October 2017
Photo of an EpiPen 2-Pak released by Mylan to show consumers where they can find the lot number and expiration date for products affected by the recall (Mylan)

It’s unclear why the initial recall didn’t include EpiPens sold in the United States, especially given the product is manufactured in St. Louis, Missouri.

Anyone who experiences problems with an existing EpiPen is encouraged by Mylan to contact the FDA.

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