FDA Extends Expiration Dates of All Lots of EpiPens® and Authorized Generic

 

As supply interruptions and shortages of epinephrine auto-injectors continue, the FDA has extended the expiration dates 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. Read the full letter to the Pfizer/Mylan HCP letterDownload PDF posted on FDA website for the new expiration dates.

There may be options if you are having trouble filling your epinephrine autoinjector prescription.


[PRESS RELEASE]

Extended use dates to assist with EpiPen intermittent supply interruptions


[June 5, 2019] 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.

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 table below with their new expiration dates and can be found on 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.

IMPACTED PRODUCT

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?

READ MORE - NEW EXTENDED EXPIRATION DATES

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