ST. LOUIS, Missouri — A U.S. regulator this week told Pfizer Inc’s Meridian Medical Technologies division, maker of the EpiPen injector device, that serious component and product failures have been associated with patient deaths and severe illness.
Reuters reported Thursday that tens of thousands of EpiPens, sold by Mylan NV, were recalled worldwide in March following two reports of the life-saving allergy shot failing to work in emergencies.
According to Forbes, if Meridian does not correct the violations, the agency said, the result may be “legal action without further notice including, without limitation, seizure and injunction”—and, ultimately, the withholding of contracts from other federal agencies.
The Tuesday warning letter noted that the manufacturer had received 171 complaints about products that failed to activate between 2014 and 2017, but did not disassemble “the vast majority” of the units as part of its investigation. The device is designed to inject epinephrine to halt dangerous allergic reactions.
“In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died,” the FDA letter said. The product flaws included the device not functioning properly when needed and the injector not having drug left when needed,” the letter said.
Meridian had to issue a recall of the EpiPen and EpiPen Jr. auto-injectors at the end of March as some of the devices, which are used for treating allergic reactions, had a defective part that potentially stopped them from working—an event that could be life-threatening.
“I think it would be an understatement to say that the results are disturbing,” Michael Carome, director of the health research group at Public Citizen, told the Washington Post. “The findings of the letter reflect a reckless disregard for public safety and patient health.”
According to IMS Health data, annual prescriptions for EpiPen products have more than doubled over the last decade to 3.6 million, the Washington Post reported Friday.
The FDA ordered Meridian to review its manufacturing investigations and provide analyses of its processes for spotting quality problems and validating component designs.
“You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness,” the warning read. “You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.”
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