In both cases, patients were fortunate to have an alternate EpiPen on hand to treat their allergic reactions.
According to Myland, the recall affects EpiPens distributed in Australia, New Zealand, Europe and Japan. The company said it is working with regulatory authorities to inform them about the recall.
EpiPen is an injectable allergy medication that contains epinephrine, a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure (hypotension), wheezing, skin itching, hives, and other symptoms of an allergic reaction.
Mylan has also recently come under fire for a massive price increase on EpiPen, which has jumped from about $100 in 2010 to the current price of more than $600.
The company has tried to ease concerns with discount coupons and programs to help families cover the cost of the EpiPen. However, some lawmakers say these efforts don’t go far enough.
“Offering a meager discount only after widespread bipartisan criticism is exactly the same tactic used by drug companies across the industry to distract from their exorbitant price increases, as our investigation has shown repeatedly,” said Congressman Elijah Cummings (D-MD). “Nobody is buying this PR move anymore.”
Meanwhile, Mylan faces at least two class action lawsuits alleging that the EpiPen price hike violated state consumer protection laws, which prohibit “unconscionable” acts in connection with consumer transactions. The company has defended the price increase, saying it spent hundreds of millions improving the product.