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Meridian Medical Technologies, a Pfizer company that makes Mylan’s EpiPen injector, has issued a nationwide, voluntary recall including the children’s version, EpiPen Jr, according to USA Today.

“The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis),” Meridian said in a statement.

The company recalled the product in several countries last month following two reports of the device failing to activate. It says one lot was found to be flawed but as a precautionary measure a total of 13 lots are being recalled from the U.S. market.

The recall will extend to Europe, Asia, North and South America, according to Mylan. It impacts the 0.3 mg and 0.15 mg strengths of Auto-Injector distributed between December 2015 and July 2016.

Mylan will replace them at no cost. Customers can contact the company on mylan.com/epipenrecall for updates on product return and replacement instructions.

Here is the list of U.S. Impacted Lots:

  • 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

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