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Important Update on EpiPen® (epinephrine injection, USP) 0.3 mg Auto-Injectors

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.

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