Here are six things to know.
- The Food and Drug Administration sent the manufacturer a warning letter Tuesday, which noted Meridian received 171 complaints between 2014 and 2017 about EpiPens failing to properly activate during emergency situations, “including some situations in which patients subsequently died.”
- The complaints detailed EpiPens that failed to activate when the user followed operating instructions and others that spontaneously dispensed epinephrine prior to activation.
- Following the complaints, Meridian 22 issued a worldwide recall for 81,000 EpiPens March, which was expanded to the U.S. in early April.
- Pfizer said these complaints are fairly typical, “especially when the product is frequently administered by non-medically trained individuals,” according to a statement cited by The Washington Post.
- In the warning letter, the FDA claimed Meridian’s investigation into the complaints was not thorough enough and called out the manufacturer for not discovering the root cause of the malfunctions.
- The agency asked Meridian to conduct a comprehensive review of its investigations, develop a plan to promote patient safety and assess quality risks for EpiPens still in distribution.
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