Extended use dates to assist with EpiPen intermittent supply interruptions

[August 21, 2018] Due to the intermittent supply interruptions of EpiPen, FDA is alerting health care professionals and patients of updated dates through which some EpiPens and the authorized generic version, manufactured by Meridian Medical Technologies, a Pfizer company, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.

Based on stability data provided by Pfizer and reviewed by FDA, the following extended use dates are supported for specific batches indicated in the tables below. Patients that have the batch numbers below will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.

FDA is not requiring or recommending that the identified batches in the following tables be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.

Please see the recent FDA in Brief for more information, and contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding these tables.

Epinephrine Injection, USP 0.3 mg Auto-Injectors
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