EpiPen Maker Neglected ‘Hundreds’ of Complaints About Defects
- Pfizer manufactures the shots, which are sold by Mylan
- Defects associated with ‘patient deaths and severe illness’
Mylan NV's EpiPen allergy shots
Photographer: Daniel Acker/BloombergThis article is for subscribers only.
A Pfizer Inc. unit that makes the life-saving allergy shot EpiPen failed to investigate hundreds of complaints about defects in the auto-injecting pens, including in cases where patients were hurt or died, according to the U.S. Food and Drug Administration.
In a warning letter sent to Pfizer’s Meridian Medical Technologies division, the FDA said the company “failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness.”