FDA warns Pfizer’s Meridian over EpiPen flaws

FDA warned about an injunction or seizure if Meridian Medical Technologies, a division of Pfizer, does not correct its problems with the EpiPen (epinephrine auto-injector).

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The EpiPen has had severe product failures, FDA said in a recent warning letter to its manufacturer.

In April, Meridian expanded a voluntary recall of the EpiPen and EpiPen Jr. epinephrine auto-Injectors to now include additional lots distributed in the United States and other markets.

“This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the US of failure to activate the device due to a potential defect in a supplier component,” Mylan said in a statement. “The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).”

Related: Major EpiPen recall issued

However, in FDA’s September 5 warning letter, the agency said that Meridian knew about the EpiPen’s problems long before the April recall.

“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,” FDA wrote. “You instructed your supplier to undertake a full investigation and corrective actions regarding [EpiPen’s] firing defect, but continued to manufacture finished products using other lots of the same component while the supplier’s investigation remained open until October 2016.”

Meridian’s failure to fix the violations promptly could lead to legal action such as injunction and seizure, according to FDA.

“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 letter from the FDA states. “You instructed your supplier to undertake a full investigation and corrective actions regarding [EpiPen’s] firing defect, but continued to manufacture finished products using other lots of the same component while the supplier’s investigation remained open until October 2016.”

FDA gave Meridian 15 working days after receiving the letter to correct the violations.

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