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Expiration Extension
On June 5, 2019, the U.S. Food and Drug Administration announced the extension of the expiration dates by four months of all lots of EPIPEN® 0.3 mg Auto-Injectors and its authorized generic version currently on the market in the U.S.
This action was based on a careful review of product stability data by Pfizer and intended to alleviate temporary supply constraints at the time of its announcement. Since then, U.S. supplies of EPIPEN and its authorized generic have stabilized to normal levels to meet demand.
The affected lots, which have current expiration dates between February 2019 and October 2020, are listed in the Impacted Product section below and can also 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. Patients must continue to adhere to the manufacturer’s expiry date labeled on EPIPEN JR 0.15 mg and Epinephrine Injection, USP Auto-Injectors 0.15 products.
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Locating Your Expiration Date
The expiration date for EPIPEN 0.3 mg Auto-Injectors and its authorized generic is located on both the carton and auto-injector itself. Please see example images.
- • On the auto-injector, the expiration date is located at the top of the label in black and preceded by the word ‘EXP.’
- • On the carton, the expiration date is located on the left flap, which is black in color. You will find the expiration date written in white and preceded by the word ‘EXP.’
You can confirm if your auto-injector's expiration date has been extended by checking if it matches any of the expiration dates listed in the Impacted Product section below.
If you have any questions regarding the expiration date of your auto-injector, please call Viatris Customer Relations at 800.796.9526.
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Impacted Product
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 boxEPIPEN® (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
NEW EXTENDED EXPIRATION DATES
Manufacturer's Original Expiration Date
New Expiration Date
Please note: Expiration dates are valid through the last day of the month listedFeb 19 Jun 19 Mar 19 Jul 19 Apr 19 Aug 19 Jun 19 Oct 19 Jul 19 Nov 19 Aug 19 Dec 19 Sep 19 Jan 20 Oct 19 Feb 20 Nov 19 Mar 20 Dec 19 (only available in Epinephrine Injection 0.3 mg) Apr 20 Jan 20 May 20 Feb 20 (only available in Epinephrine Injection 0.3 mg) Jun 20 Mar 20 (only available in Epinephrine Injection 0.3 mg) Jul 20 Apr 20 Aug 20 May 20 (only available in Epinephrine Injection 0.3 mg) Sep 20 Jun 20 Oct 20 Aug 20 (only available in Epinephrine Injection 0.3 mg) Dec 20 Sept 20 Jan 21 Oct 20 (only available in Epinephrine Injection 0.3 mg) Feb 21
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Resources
• Healthcare provider letter on expiration extension
For general inquiries, please contact Viatris Customer Relations at 800-796-9526 or customer.service@viatris.com. Viatris Customer Relations hours of operations are Monday through Friday, 8 a.m. to 5 p.m. ET.
For medical related inquiries, related to EPIPEN auto-injectors or to report an adverse event, please contact Viatris Medical Information at 1-877-4INFO-RX (1-877-446-3679) or ViatrisMICC@Viatris.com.
Need Help?
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If you are experiencing difficulty accessing product, please call Viatris' Customer Relations for assistance in locating other pharmacies at 800.796.9526 M-F, 8a-5p ET.
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INDICATIONS (the following information applies to both EPIPEN and its Authorized Generic)
EPIPEN® and EPIPEN JR® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN of EPIPEN JR.
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