Just as the furor over pricing had died down, the EpiPen is back in the spotlight with Mylan recalling more than 80,000 of the injectors outside the U.S. because they may not work.
The injectors were manufactured for Mylan by Pfizer’s Meridian Medical Technologies, a unit which has been at the center of unwanted attention for its injectors before.
Mylan this week issued a recall of four batches of its EpiPen 300 microgram injectors shipped to Europe, Japan, Australia and New Zealand. The recall followed two confirmed reports that the devices may contain a defective part that could result in the pen either not activating or requiring extra force to activate, the company said.
That, as Mylan pointed out, could be a problem for someone being injected for anaphylaxis or anaphylactic reactions. It said that "at this time" its EpiPen Jr pens, its 150 pens and all of the EpiPen 300 injectors outside of the identified batches were okay to use.
The pens were manufactured for Mylan by Pfizer’s Meridian unit in St. Louis, Missouri. The Pfizer operation ran into trouble with a Congressman in 2013 when it had to replace injectors sold to the military that were to be used in case of a sarin gas attack. Pfizer had discovered that about 7 out of 1,000 of its DuoDote auto-injectors containing atropine and pralidoxime didn't contain enough of one or both of the drugs.
At the time, there had been a confirmed report that Syria had used sarin in a rocket attack in its civil war that killed hundreds.
The current recall comes as attention on EpiPen pricing has subsided somewhat. Mylan CEO Heather Bresch spent the second half of last year dealing with public and political outrage after reports showed Mylan had raised the price repeatedly for the pens as its lock on the market tightened. It also struck a $465 million settlement with the Justice Department to resolve allegations that it overcharged Medicaid for EpiPen.