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Drug Safety Alerts
EpiPen® 2-Pak® Auto-Injectors 0.3 mg and EpiPen Jr. 2-Pak Patient-Level Recall
3/31/2017
On March 31, 2017, the United States Food and Drug Administration (FDA) issued a notice regarding a patient-level recall of EpiPen® 2-Pak® Auto-Injectors 0.3 mg and EpiPen Jr. 2-Pak Auto-Injectors 0.15 mg. This recall was issued as a result of the receipt of two previously disclosed reports outside of the United States of failure to activate the device due to a potential defect in a supplier component. 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). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare 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.
A complete list of the affected products and lot numbers distributed in the United States is provided here.
The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.
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.
CVS Caremark Response: Because of this action, CVS Caremark is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians.
For more information about this recall, health care providers may contact Mylan Customer Relations at 1‑800‑796‑9526 or visit www.mylan.com/EpiPenRecall. You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.