EpiPen and Mylan Generic Epinephrine Autoinjector Expiration Dates Extended for Some Lots.

Extended Use Dates Provided by Pfizer

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

Batch Manufacturer’s Original
Expiration Date
New Expiration Date
(beyond manufacturer’s
original expiry date)
6FM722 4/2018 8/2018
6FM739 4/2018 8/2018
6FM771 4/2018 8/2018
6FM772 4/2018 8/2018
6FM773 4/2018 8/2018
6FM715 5/2018 9/2018
6FM716 5/2018 9/2018
6FM756 5/2018 9/2018
6FM757 5/2018 9/2018
6FM768 5/2018 9/2018
6FM780 5/2018 9/2018
6FM781 5/2018 9/2018
6FM782 5/2018 9/2018
6FM783 5/2018 9/2018
6FM785 6/2018 10/2018
6FM787 6/2018 10/2018
7FM115 8/2018 12/2018
7FM117 8/2018 12/2018
7FM120 8/2018 12/2018
7FM134 8/2018 12/2018
7FM174 9/2018 1/2019
7FM175 9/2018 1/2019
7FM274 10/2018 2/2019
7FM275 10/2018 2/2019
7FM276 10/2018 2/2019

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

Batch Manufacturer’s Original
Expiration Date
New Expiration Date
(beyond manufacturer’s
original expiry date)
6GM480 4/2018 8/2018
6GM481 4/2018 8/2018
6GM503 4/2018 8/2018
6GM504 4/2018 8/2018
6GM506 4/2018 8/2018
6GM507 4/2018 8/2018
6GM512 4/2018 8/2018
6GM669 4/2018 8/2018
6GM599 5/2018 9/2018
6GM685 6/2018 10/2018
6GM766 6/2018 10/2018
6GM767 6/2018 10/2018
7GM026 8/2018 12/2018
7GM045 8/2018 12/2018
7GM048 9/2018 1/2019
7GM054 9/2018 1/2019
7GM164 9/2018 1/2019
7GM172 9/2018 1/2019
7GM173 9/2018 1/2019
7GM272 9/2018 1/2019
7GM191 10/2018 2/2019
7GM200 11/2018 3/2019
7GM201 11/2018 3/2019
7GM203 12/2018 4/2019
7GM204 12/2018 4/2019
7GM212 12/2018 4/2019
7GM213 12/2018 4/2019
7GM360 12/2018 4/2019
7GM361 12/2018 4/2019