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

To address shortages of EpiPen, Pfizer is coordinating with FDA to extend the expiration dates of specific lots of EpiPen® 0.3 mg Auto-Injectors and its authorized generic version after review of stability data. 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.

This announcement is based on a careful review of product stability 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 the 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, are indicated in the tables below with their new expiration dates and 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 of this strength. 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 mg products.

Please watch this important video from Pfizer’s Chief Medical Officer, Dr. Freda Lewis-Hall, regarding this announcement.

Meridian, a subsidiary of Pfizer that manufactures EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, continues to experience manufacturing constraints affecting supply. Mylan and Pfizer place great importance on the consistent availability of EpiPen for everyone who needs it. Pfizer is working tirelessly to increase production and expedite shipments as rapidly as possible. Currently, supplies will vary from pharmacy to pharmacy, and we cannot guarantee that product will be available at all pharmacies.

We understand the challenges this situation continues to pose to patients. Ensuring continuity of the supply of our medicines is paramount.

Mylan, the distributor, is expediting shipments upon receipt from Pfizer and continues to encourage patients who are experiencing difficulty accessing product to call its Customer Relations team at 800-796-9526 for assistance in locating other pharmacies. To further assist patients during this period of limited supply, Mylan recently extended its Customer Relations hours to Monday through Friday, 8 a.m. to 7 p.m. ET.

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

Lot NumberManufacturer’s Original Expiry DateNew Expiration Date (beyond manufacturer’s original expiry date)
6FM722Apr 18Aug 18
6FM739Apr 18Aug 18
6FM771Apr 18Aug 18
6FM772Apr 18Aug 18
6FM773Apr 18Aug 18
6FM715May 18Sep 18
6FM716May 18Sep 18
6FM756May 18Sep 18
6FM757May 18Sep 18
6FM768May 18Sep 18
6FM780May 18Sep 18
6FM781May 18Sep 18
6FM782May 18Sep 18
6FM783May 18Sep 18
6FM785Jun 18Oct 18
6FM787Jun 18Oct 18
7FM115Aug 18Dec 18
7FM117Aug 18Dec 18
7FM120Aug 18Dec 18
7FM134Aug 18Dec 18
7FM174Sep 18Jan 19
7FM175Sep 18Jan 19
7FM274Oct 18Feb 19
7FM275Oct 18Feb 19
7FM276Oct 18Feb 19

 

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

Lot NumberManufacturer’s Original Expiry DateNew Use Date (beyond manufacturer’s original expiry date)
6GM480Apr 18Aug 18
6GM481Apr 18Aug 18
6GM503Apr 18Aug 18
6GM504Apr 18Aug 18
6GM506Apr 18Aug 18
6GM507Apr 18Aug 18
6GM512Apr 18Aug 18
6GM669Apr 18Aug 18
6GM599May 18Sep 18
6GM685Jun 18Oct 18
6GM766Jun 18Oct 18
6GM767Jun 18Oct 18
7GM026Aug 18Dec 18
7GM045Aug 18Dec 18
7GM048Sep 18Jan 19
7GM054Sep 18Jan 19
7GM164Sep 18Jan 19
7GM172Sep 18Jan 19
7GM173Sep 18Jan 19
7GM272Sep 18Jan 19
7GM191Oct 18Feb 19
7GM200Nov 18Mar 19
7GM201Nov 18Mar 19
7GM203Dec 18Apr 19
7GM204Dec 18Apr 19
7GM212Dec 18Apr 19
7GM213Dec 18Apr 19
7GM360Dec 18Apr 19
7GM361Dec 18Apr 19