The shocking revelation is in a warning letter that the FDA sent to a Pfizer division that makes the EpiPens for Mylan another pharmaceutical giant.
It wasn't until the FDA urged the company to look at the issue more closely, the warning letter says, that the Pfizer operation discovered that its supplier had produced a "deformed" part that was used in multiple lots of EpiPen products, 13 of which had been distributed in the U.S. It was only at that point the Meridian recalled the potentially defective units.
From 2014 to 2015, Meridian records indicated that the company received 171 samples of EpiPens that were related to user complaints and had failed to activate even though the patient had followed the operational instructions properly.
It claimed that in some cases people had died after the device, which delivers a dose of epinephrine to people suffering from severe allergic reaction known as anaphylaxis, failed to work properly. However, this only happened after the FDA inspected the way these products were operating. "It's not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals".
Meridian Medical Technologies also discovered that a critical component of the auto-injector product failed a year ago, the FDA inspection which triggered the letter found.
Mylan doesn't expect a shortage of product because of the warning and is "confident in the safety and efficacy of EpiPen products being produced at the site", it said in a statement. "We now have no information to show that there was any causal connection between these product complaints and any patient deaths".
In a letter published this week, the agency said these deaths would have been preventable had the makers of EpiPen tested their products, or at least investigated malfunctioning reports more thoroughly.
The FDA letter demands that Meridian respond with a comprehensive review of manufacturing processes and "plans for addressing the patient safety and product quality risks for product still in distribution".
But the FDA letter paints a different picture of the circumstances, saying that Meridian closed one device failure complaint in June 2016, which involved that same suspect device-firing component.
Meridian rejected that lot and another associated lot and called on its supplier to investigate the causes for the defective parts.
In a statement, Pfizer expressed confidence in the EpiPen's reliability and distanced the device from the FDA's association to fatalities.
The FDA is giving Pfizer Inc.
It concluded: "Correct the violations cited in this letter promptly".
In an emailed response today, Pfizer said, "Patient safety is of primary importance to Pfizer".
"Both problems result in the patient not receiving the needed drug in a life-threatening situation", the FDA wrote. It expressed confidence in the quality of EpiPen products and noted: "we do not now anticipate any supply issues as a result of the warning letter".
The FDA asks consumers to report any adverse reactions or quality problems here.