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Epi-Pen information
 

Extended Use Dates Provided by Pfizer

Extended use dates to assist with EpiPen intermittent supply interruptions

[August 21, 2018] Due to the intermittent supply interruptions of EpiPen, FDA is alerting health care professionals and patients of updated dates through which some EpiPens and the authorized generic version, manufactured by Meridian Medical Technologies, a Pfizer company, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.

Based on stability data provided by Pfizer and reviewed by FDA, the following extended use dates are supported for specific batches indicated in the tables below. Patients that have the batch numbers below will be able to use them through the corresponding new use dates to help with supply. As data become available, this list can continue to expand.

FDA is not requiring or recommending that the identified batches in the following tables be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects the lots in these tables will be replaced and properly disposed of as soon as possible.

Please see the recent FDA in Brief for more information, and contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding these tables.

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

BatchManufacturer's Original
Expiration Date
New Expiration Date
(beyond manufacturer's
original expiry date)
6FM7224/20188/2018
6FM7394/20188/2018
6FM7714/20188/2018
6FM7724/20188/2018
6FM7734/20188/2018
6FM7155/20189/2018
6FM7165/20189/2018
6FM7565/20189/2018
6FM7575/20189/2018
6FM7685/20189/2018
6FM7805/20189/2018
6FM7815/20189/2018
6FM7825/20189/2018
6FM7835/20189/2018
6FM7856/201810/2018
6FM7876/201810/2018
7FM1158/201812/2018
7FM1178/201812/2018
7FM1208/201812/2018
7FM1348/201812/2018
7FM1749/20181/2019
7FM1759/20181/2019
7FM27410/20182/2019
7FM27510/20182/2019
7FM27610/20182/2019

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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

BatchManufacturer's Original
Expiration Date
New Expiration Date
(beyond manufacturer's
original expiry date)
6GM4804/20188/2018
6GM4814/20188/2018
6GM5034/20188/2018
6GM5044/20188/2018
6GM5064/20188/2018
6GM5074/20188/2018
6GM5124/20188/2018
6GM6694/20188/2018
6GM5995/20189/2018
6GM6856/201810/2018
6GM7666/201810/2018
6GM7676/201810/2018
7GM0268/201812/2018
7GM0458/201812/2018
7GM0489/20181/2019
7GM0549/20181/2019
7GM1649/20181/2019
7GM1729/20181/2019
7GM1739/20181/2019
7GM2729/20181/2019
7GM19110/20182/2019
7GM20011/20183/2019
7GM20111/20183/2019
7GM20312/20184/2019
7GM20412/20184/2019
7GM21212/20184/2019
7GM21312/20184/2019
7GM36012/20184/2019
7GM36112/20184/2019