Latest Supply Status

Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, continues to experience manufacturing constraints affecting supply. Currently, supplies will vary from pharmacy to pharmacy, and may not always be available.

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

On Aug. 21, 2018, the U.S. Food and Drug Administration announced to extend the expiration dates of specific lots of EpiPen 0.3 mg Auto-Injectors and its authorized generic version. 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.

Pfizer and Mylan's recommendation to extend the expiration dates of specific lots, and the FDA's decision were based on a careful review of 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 its 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 listed in tables in the expandable sections 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 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 products.

  • Locating Your Auto-Injector Lot Number

    Lot number and expiration date for EpiPen 0.3 mg Auto-Injectors and its authorized generic are located on both the carton and auto-injector itself. Please see example images.

    •  • On the auto-injector, the lot number is located at the top of the label in black and preceded by the word ‘LOT.’
    •  • On the carton, the lot number is located on the left flap, which is black in color. You will find the lot number written in white and preceded by the word ‘LOT.’

    You can confirm if your auto-injector's expiration date has been extended by checking if its lot number matches any of the lot numbers listed in the expandable sections below.

    If you have any questions regarding the lot number or expiration date of your auto-injector, please call Mylan Customer Relations at 800.796.9526.

  • EpiPen 0.3 mg Auto-Injector Lot Numbers with Extended Expiration Dates

    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

    Please note: Expiration dates are valid through the last day of the month listed

    Lot Number Manufacturer's Original Expiration Date New Expiration 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
  • Epinephrine Injection, USP Auto-Injector 0.3 mg Lot Numbers with Extended Expiration Dates

    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

    Please note: Expiration dates are valid through the last day of the month listed

    Lot Number Manufacturer's Original Expiration 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
  • U.S. EpiPen Supply Frequently Asked Questions (FAQ)

    1. What is the reason for the supply constraints?

    Mylan’s manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic version of these strengths. Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies. Pfizer is working hard to increase production and stabilize supplies, but until this occurs, supplies of EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, will continue to vary from pharmacy to pharmacy and may not always be available.

    2. Who manufactures EpiPen and EpiPen Jr?

    Meridian Medical Technologies, a Pfizer company, manufactures EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths.

    3. What is Mylan’s role?

    Mylan sells and distributes EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths. Mylan is not the manufacturer.

    4. When will the supply constraints be fully resolved?

    Pfizer anticipates supply will stabilize in the fourth quarter of 2018.

    5. What are Mylan and Pfizer doing to resolve the supply constraint?

    We believe the extension of the expiration date will temporarily address patients’ access to and use of EpiPen 0.3 mg Auto-Injectors, and its authorized generic, particularly during back-to-school season as demand increases. Pfizer is working tirelessly to increase production. Mylan is expediting shipments upon receipt from Pfizer. We also are working closely with Pfizer to stay informed of anticipated shipments and are maintaining regular dialogue with health authorities to provide frequent updates on supply status.

    6. Does the supply constraint affect the EpiPen4Schools® program?

    Mylan is continuing to support the EpiPen4Schools program, which offers four free epinephrine auto-injectors to qualifying public and private kindergarten, elementary, middle and high schools in the U.S. each calendar year. In May, we communicated to all schools participating in the program that given Pfizer’s intermittent supply constraints of EpiPen Auto-Injector 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions of these strengths, there may be delays in order fulfillment until supply levels stabilize.

    7. Who should I contact if I have additional questions?

    For general inquiries, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com. Mylan Customer Relations hours of operations are Monday through Friday, 8 a.m. to 7 p.m. ET.

    If you have an inquiry of a medical nature related to EpiPen Auto-Injectors or to report an adverse event, please contact Mylan Medical Information at 1-877-4INFO-RX (1-877-446-3679) or MylanMICC@Mylan.com.

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Need Help?

If you are experiencing difficulty accessing product, please call Mylan's Customer Relations for assistance in locating other pharmacies at 800.796.9526 M-F, 8a-7p ET.

More Important Safety Information

Use EpiPen® (epinephrine injection, USP) 0.3 mg or EpiPen Jr® (epinephrine injection, USP) 0.15 mg Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. EpiPen® or EpiPen Jr® should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

Rarely, patients who have used EpiPen® or EpiPen Jr® may develop an infection at the injection site within a few days. Some of these infections can be serious. Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use EpiPen® or EpiPen Jr®.

Common side effects include fast, irregular or “pounding” heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Indications

EpiPen® and EpiPen Jr®  Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen® and EpiPen Jr® are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.


Please see the full Prescribing Information and Patient Information.

For additional information please contact us at 800-395-3376.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

EpiPen® & EpiPen Jr® (epinephrine injection, USP) Auto-Injectors 0.3/0.15mg

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