Major EpiPen recall issued

Meridian Medical Technologies, Mylan's manufacturing partner for the EpiPen Auto-Injector, 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: Drug maker pays out millions over EpiPen charges

The expanded voluntary recall is starting in the U.S. and will extend to additional markets in Europe, Asia, North and South America. Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement, based on availability, according to Mylan.

The incidence of the defect is extremely rare, Mylan said, and testing and analysis across the potentially impacted lots has not identified any units with a defect. “However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.”

The recalled EpiPen and EpiPen Jr. auto-injectors were manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December, 2015 and July, 2016. The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies. 

Related: Cheaper generic EpiPen doesn't quiet critics

“Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall,” the company said in a statement.

It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.

Patients, customers and distributors should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. To return product, contact Stericycle at 877-650-3494. For questions on the recall, call Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com.

Read more: EpiPen discounts offered after pricing flap