EpiPen is back in the news, and not for good reasons. The U.S. Food and Drug Administration has made claims that Pfizer, the company who makes the pens, did disclose proper information of defected pens. Hundreds of complaints were sent, and in some cases, there was death.
The FDA sent out a warning letter to Pfizer’s Meridian Medical Technologies division. In the letter, the FDA says that the company did not thoroughly investigate the complaints.
The EpiPens come from a factory in Mylan NV. They also sell the injectors. They were once in the news for the outrageous price of the pens.
A spokeswoman who works with the FDA says that the agency did know of the adverse events that came about with the EpiPen. They did not give out any more information.
The company has not worries about there being a shortage of the EpiPen.
They believe in their product’s safety.
In the letter, The FDA also said that Pfizer did not investigate any of the serious and life threatening complaints. Nor did they take any action.
There times when the epinephrine within the EpiPens was seeping out.
When a person goes to use the pen, they will find that it is completely empty. In other instances, the injector part of the pen did not work.
Also, the company did not do an efficient job of removing pens that were defective from the market. This was even after noting that some pens were faulty.
Between the years 2014 and 2017, at least 171 product complaints were sent to Pfizer. The company, for some reason, chose to not disassemble the samples.
Pfizer shares this week were at a stable $33.99.
The FDA wants Meridian to correct the issues immediately. The inspections occurred in Brentwood, Missouri. Also, the investigation was from Feb. 20 through the end of March. All of this information was in the note.