Drug Safety Alerts

Extended Expiration Dates for Select Lots of EpiPen® 0.3 mg Auto-Injectors and its Authorized Generic

8/21/18

On Aug. 21, 2018, the U.S. Food and Drug Administration announced that it is supporting the extension of the expiration dates of specific lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic version. Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 2018.

Pfizer and Mylan's recommendation to extend the expiration dates of specific lots, and the FDA's decision were based on a careful review of data provided by Pfizer. We believe the extension of the expiration date will temporarily address patients’ access to and use of EpiPen 0.3 mg Auto-Injectors, and its authorized generic, particularly during back-to-school season as demand increases.

The affected lots, which have current expiration dates between April 2018 and December 2018 can be found on FDA’s website. 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 should 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.

For more information on this issue, visit the manufacturer’s website at www.epipen.com/en/about-epipen-and-generic/supply-information and/or FDA’s website at www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm617724.htm.