To address continued shortages of EpiPen®, Pfizer and Mylan are coordinating with FDA to extend the expiration dates by four months of all lots of EpiPen® (epinephrine injection, USP) 0.3 mg Auto-Injectors and its authorized generic version currently on the market in the U.S. after a review of stability data. Patients should have confidence in using the products as Pfizer works to stabilize supply.
This announcement is based on a careful review of product stability data provided by Meridian Medical Technologies, Inc., a subsidiary of Pfizer, that manufactures EpiPen® Auto-Injectors and the authorized generic versions.
The affected lots, which have current expiration dates between February 2019 and October 2020, are listed in a table on the following page with their new expiration dates and can be found on FDA’s website and EpiPen.com/EpiPenSupply. The extension of the expiration dates does not apply to EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors and its authorized generic version. Patients must continue to adhere to the manufacturer’s expiry date labeled on EpiPen Jr® 0.15 mg and Epinephrine Injection, USP Auto-Injectors 0.15 products.
EpiPen is a product that requires a highly complex and technical manufacturing and assembly process. Meridian continues to experience manufacturing challenges. These challenges are expected to result in tighter supplies and greater variability in pharmacy-level access over the coming weeks and will potentially continue through the summer months as seasonal demand increases.
- Epinephrine Injection, USP Auto-Injectors 0.3 mg
- NDC 49502-102-02 appears on the box
- NDC 49502-102-01 appears on the individual device within the box
- EpiPen® (epinephrine injection, USP) 0.3 mg Auto-Injectors
- NDC 49502-500-02 appears on the box
- NDC 49502-500-01 appears on the individual device within the box