EpiPen, EpiPen Jr. recall expands to U.S.
Mylan's original March 20 recall affected about 80,000 of the EpiPen devices shipped to locations outside the United States.
Mylan announced that the additional recalled items were part of 13 lots of EpiPen (0.3 mg) and EpiPen Jr. (0.15 mg) 2-Pak Auto-Injectors that carry expiration dates between April and October.
Mylan brands adult versions with a yellow label and junior devices with a green label.
The company said the recalls are the result of two reported EpiPen failures that occurred outside the United States - due to a "potential defect in a supplier component" - and that more than 80,000 auto-injectors could contain the fault.
"The potential defect could make the device difficult to activate in an emergency and have significant health consequences for a patient experiencing a life-threatening allergic reaction," Mylan said in a statement. ■