Extended Expiration Dates for Select Lots of EpiPen® 0.3 mg AutoInjectors 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 LewisHall, 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 and Saturday through Sunday, 11 a.m. to 4 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 Number
Manufacturer’s Original Expiry Date
New Expiration Date (beyond manufacturer’s original expiry date)
6FM722
Apr 18
Aug 18
6FM739
Apr 18
Aug 18
6FM771
Apr 18
Aug 18
6FM772
Apr 18
Aug 18
6FM773
Apr 18
Aug 18
6FM715
May 18
Sep 18
6FM716
May 18
Sep 18
6FM756
May 18
Sep 18
6FM757
May 18
Sep 18
6FM768
May 18
Sep 18
6FM780
May 18
Sep 18
6FM781
May 18
Sep 18
6FM782
May 18
Sep 18
6FM783
May 18
Sep 18
6FM785
Jun 18
Oct 18
6FM787
Jun 18
Oct 18
7FM115
Aug 18
Dec 18
7FM117
Aug 18
Dec 18
7FM120
Aug 18
Dec 18
7FM134
Aug 18
Dec 18
7FM174
Sep 18
Jan 19
7FM175
Sep 18
Jan 19
7FM274
Oct 18
Feb 19
7FM275
Oct 18
Feb 19
7FM276
Oct 18
Feb 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 Number
Manufacturer’s Original Expiry Date
New Use Date (beyond manufacturer’s original expiry date)
6GM480
Apr 18
Aug 18
6GM481
Apr 18
Aug 18
6GM503
Apr 18
Aug 18
6GM504
Apr 18
Aug 18
6GM506
Apr 18
Aug 18
6GM507
Apr 18
Aug 18
6GM512
Apr 18
Aug 18
6GM669
Apr 18
Aug 18
6GM599
May 18
Sep 18
6GM685
Jun 18
Oct 18
6GM766
Jun 18
Oct 18
6GM767
Jun 18
Oct 18
7GM026
Aug 18
Dec 18
7GM045
Aug 18
Dec 18
7GM048
Sep 18
Jan 19
7GM054
Sep 18
Jan 19
7GM164
Sep 18
Jan 19
7GM172
Sep 18
Jan 19
7GM173
Sep 18
Jan 19
7GM272
Sep 18
Jan 19
7GM191
Oct 18
Feb 19
7GM200
Nov 18
Mar 19
7GM201
Nov 18
Mar 19
7GM203
Dec 18
Apr 19
7GM204
Dec 18
Apr 19
7GM212
Dec 18
Apr 19
7GM213
Dec 18
Apr 19
7GM360
Dec 18
Apr 19
7GM361
Dec 18
Apr 19
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