Important Update on EpiPen (epinephrine injection, USP) 0.3 mg Auto-Injectors from Mylan and Pfizer

Transcription

1 August 21, 2018 Important Update on EpiPen (epinephrine injection, USP) 0.3 mg Auto-Injectors from Mylan and Pfizer Extended Expiration Dates for Select Lots of EpiPen 0.3 mg Auto- Injectors 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 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 listed in tables on the following pages with their new expiration dates and can be found on FDA s website ( and EpiPen.com ( 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 mg products. Visit Pfizer s YouTube channel ( to watch an important video from Pfizer s Chief Medical Officer, Dr. Freda Lewis-Hall, 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. Page 1 of 4

2 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 for assistance in locating alternative 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. Sincerely, Roslyn F. Schneider, M.D., FACP, FCCP Global Patient Affairs Lead, Pfizer Inc Rafael Muniz, M.D. Head of Global Medical Affairs, Mylan Inc. Please review the list of EpiPen 0.3 mg Auto-Injectors and Epinephrine Injection, USP Auto-Injectors 0.3 mg lots on the following pages with extended expiration dates. Page 2 of 4

3 Click Ctrl F on your key board to search your lot number. Epinephrine Injection, USP Auto-Injectors 0.3 mg NDC appears on the box NDC appears on the individual device within the box New Expiration Date Lot Manufacturer's Original Expiration Date (beyond manufacturer's 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 SECOND TABLE ON NEXT PAGE Page 3 of 4

4 EpiPen (epinephrine injection, USP) 0.3 mg Auto-Injectors NDC appears on the box NDC appears on the individual device within the box New Expiration Date Lot Manufacturer's Original Expiration Date (beyond manufacturer's 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 Page 4 of 4

5 Page 1 of 20 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 (/NewsEvents/Newsroom/FDAInBrief/ucm htm) for more information, and contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov (mailto:drugshortages@fda.hhs.gov) with questions regarding these tables. Epinephrine Injection, USP 0.3 mg Auto-Injectors NDC appears on the box NDC appears on the individual device within the box Batch Manufacturer's Original Expiration Date New Expiration Date (beyond manufacturer's 6FM722 4/2018 8/2018 6FM739 4/2018 8/2018 6FM771 4/2018 8/2018 6FM772 4/2018 8/2018 6FM773 4/2018 8/2018

6 Page 2 of 20 Batch Manufacturer's Original Expiration Date New Expiration Date (beyond manufacturer's 6FM715 5/2018 9/2018 6FM716 5/2018 9/2018 6FM756 5/2018 9/2018 6FM757 5/2018 9/2018 6FM768 5/2018 9/2018 6FM780 5/2018 9/2018 6FM781 5/2018 9/2018 6FM782 5/2018 9/2018 6FM783 5/2018 9/2018 6FM785 6/ /2018 6FM787 6/ /2018 7FM115 8/ /2018 7FM117 8/ /2018 7FM120 8/ /2018 7FM134 8/ /2018 7FM174 9/2018 1/2019 7FM175 9/2018 1/2019 7FM274 10/2018 2/2019 7FM275 10/2018 2/2019 7FM276 10/2018 2/2019 Back to Top

7 Page 3 of 20 EpiPen (epinephrine injection, USP) 0.3 mg Auto-Injectors NDC appears on the box NDC appears on the individual device within the box Batch Manufacturer's Original Expiration Date New Expiration Date (beyond manufacturer's 6GM480 4/2018 8/2018 6GM481 4/2018 8/2018 6GM503 4/2018 8/2018 6GM504 4/2018 8/2018 6GM506 4/2018 8/2018 6GM507 4/2018 8/2018 6GM512 4/2018 8/2018 6GM669 4/2018 8/2018 6GM599 5/2018 9/2018 6GM685 6/ /2018 6GM766 6/ /2018 6GM767 6/ /2018 7GM026 8/ /2018 7GM045 8/ /2018 7GM048 9/2018 1/2019 7GM054 9/2018 1/2019 7GM164 9/2018 1/2019 7GM172 9/2018 1/2019 7GM173 9/2018 1/2019 7GM272 9/2018 1/2019 7GM191 10/2018 2/2019

8 Page 4 of 20 Batch Manufacturer's Original Expiration Date New Expiration Date (beyond manufacturer's 7GM200 11/2018 3/2019 7GM201 11/2018 3/2019 7GM203 12/2018 4/2019 7GM204 12/2018 4/2019 7GM212 12/2018 4/2019 7GM213 12/2018 4/2019 7GM360 12/2018 4/2019 7GM361 12/2018 4/2019 Back to Top Extended use dates to assist with emergency syringe shortages [June 12, 2018] This is to update and consolidate the information posted here previously on 6/15/17, 6/23/17, 7/19/17, 8/17/17, and 11/9/2017. Due to the ongoing critical shortage of injectable drugs used in critical care, FDA is alerting health care professionals and emergency responders of updated dates through which some of these injectable drugs, manufactured by Hospira Inc, 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 lots indicated in the table below for the following products: Atropine Sulfate Injection, USP 0.1 mg/ml; 5 ml Abboject syringe (NDC ) Atropine Sulfate Injection, USP 0.1 mg/ml; 10 ml Abboject syringe (NDC ) Atropine Sulfate Injection, USP 0.1 mg/ml; 10 ml Ansyr Plastic syringe (NDC ) Dextrose injection, USP 50% (0.5 g/ml); 25 g/50 ml Abboject syringe (NDC ) Dextrose injection, USP 50% (0.5 g/ml); 25 g/50 ml Ansyr Plastic Syringe (NDC ) Epinephrine Injection, USP 0.1 mg/ml; 10 ml Abboject syringe (NDC ) (bundle of 10 syringes) and NDC (1 syringe) Sodium Bicarbonate Injection, USP 8.4% (1 meq/ml); 50 meq/50 ml Abboject Glass Syringe (18 G x 1 ½" needle) (NDC ) Sodium Bicarbonate Injection, USP 8.4% (1 meq/ml); 50 meq/50 ml Single Dose Glass Fliptop Vial (NDC )

9 Page 5 of 20 Sodium Bicarbonate Injection, USP 8.4% (1 meq/ml); 50 meq/50 ml Single Dose Glass Fliptop Vial (NDC ) LABELLED AS NOVAPLUS Hospitals that have the following lot numbers in stock 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 lots in the following tables be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then it is expected that the lots in these tables will be replaced and properly disposed of as soon as possible. Further information is here ( Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov ( with questions regarding these tables. Back to Top Atropine Sulfate Injection, USP 0.1 mg/ml; 5 ml ABBOJECT syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 63183DK00 1-Mar Sep DK00 1-Apr Oct DK00 1-Jul Jan DK00 1-Sep Mar-2019 Back to Top Atropine Sulfate Injection, USP 0.1 mg/ml; 10 ml ABBOJECT syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 56053DK00 1-Aug Aug DK00 1-Sep Sep-2018

10 Page 6 of DK00 1-Sep Sep DK00 1-Sep Sep DK00 1-Sep Sep DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Oct Oct DK00 1-Nov Nov DK00 1-Nov Nov DK00 1-Nov Nov DK00 1-Nov Nov DK00 1-Feb Feb DK00 1-Mar Mar DK00 1-Mar Mar DK00 1-Mar Mar DK00 1-Mar Mar DK00 1-Apr Apr DK00 1-Apr Apr DK00 1-Apr Apr DK00 1-May May DK00 1-Jun Jun DK00 1-Jul Jul DK00 1-Jul Jul DK00 1-Nov Nov-2019 Back to Top

11 Page 7 of 20 Atropine Sulfate Injection, USP 0.1 mg/ml; 10 ml Ansyr Plastic syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 62292EV00 1-Feb Aug EV00 1-Feb Aug EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Oct Apr EV00 1-Oct Apr EV00 1-Oct Apr EV00 1-Oct Apr EV00 1-Nov May EV00 1-Nov May EV00 1-Nov May-2019 Back to Top Dextrose 50% Injection, USP, 50 ml ABBOJECT Syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 55177DK00 1-Jul Jul DK00 1-Jul Jul DK00 1-Aug Aug DK00 1-Aug Aug-2018

12 Page 8 of DK00 1-Aug Aug DK00 1-Oct Oct DK00 1-Nov Nov DK00 1-Mar Mar DK00 1-Mar Mar DK00 1-Mar Mar DK00 1-Apr Apr DK00 1-Apr Apr DK00 1-May May DK00 1-Jun Jun DK00 1-Jun Jun DK00 1-Jul Jul DK00 1-Jul Jul DK00 1-Jul Jul DK00 1-Aug Aug DK00 1-Aug Aug-2019 Back to Top Dextrose injection 50% (0.5 g/ml); 25 g/50 ml Ansyr Plastic Syringe (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 61036EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Jan Jul-2018

13 Page 9 of EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Feb Aug EV00 1-Feb Aug EV00 1-Feb Aug EV00 1-Feb Aug EV00 1-Mar Sep EV00 1-Mar Sep EV00 1-Mar Sep EV00 1-Mar Sep EV00 1-Mar Sep EV00 1-Mar Sep EV00 1-Mar Sep EV00 1-Mar Sep EV00 1-Apr Oct EV00 1-Apr Oct EV00 1-Apr Oct EV00 1-May Nov EV00 1-May Nov EV00 1-May Nov EV00 1-May Nov EV00 1-Jun Dec EV00 1-Jun Dec-2018

14 Page 10 of EV00 1-Jun Dec EV00 1-Jul Jan EV00 1-Jul Jan EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Aug Feb EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Sep Mar EV00 1-Oct Apr EV00 1-Oct Apr EV00 1-Oct Apr EV00 1-Oct Apr EV00 1-Nov May-2019

15 Page 11 of EV00 1-Nov May EV00 1-Nov May EV00 1-Nov May EV00 1-Nov May EV00 1-Nov May EV00 1-Nov May EV00 1-Nov May EV00 1-Dec Jun EV00 1-Dec Jun EV00 1-Dec Jun EV00 1-Dec Jun EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Jan Jul EV00 1-Jan Jul-2019 Back to Top Epinephrine Injection, USP 0.1 mg/ml; 10 ml ABBOJECT syringe (NDC ) (bundle of 10 syringes) and (NDC ) (1 syringe) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 62359DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug-2018

16 Page 12 of DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Nov Aug DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep DK00 1-Dec Sep-2018

17 Page 13 of DK00 1-Dec Sep DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Jan Oct DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov DK00 1-Feb Nov-2018

18 Page 14 of DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Mar Dec DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-Apr Jan DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb-2019

19 Page 15 of DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-May Feb DK00 1-Jun Mar DK00 1-Jun Mar DK00 1-Jun Mar DK00 1-Jun Mar DK00 1-Jun Mar DK00 1-Jul Apr DK00 1-Jan Oct DK00 1-Jan Oct-2019 Back to Top Sodium Bicarbonate Injection, USP 8.4% (1 meq/ml); 50 meq/50 ml Abboject Glass Syringe (18 G x 1 ½" needle (NDC )) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 62429DK00 1-Feb Aug-2018

20 Page 16 of DK00 1-Feb Aug DK00 1-Feb Aug DK00 1-Feb Aug DK00 1-Feb Aug DK00 1-Feb Aug DK00 1-Feb Aug DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Mar Sep DK00 1-Apr Oct DK00 1-Apr Oct DK00 1-Apr Oct DK00 1-Apr Oct DK00 1-Apr Oct DK00 1-Apr Oct DK00 1-Apr Oct DK00 1-Apr Oct DK00 1-May Nov DK00 1-May Nov-2018

21 Page 17 of DK00 1-May Nov DK00 1-May Nov DK00 1-May Nov DK00 1-May Nov DK00 1-May Nov DK00 1-May Nov DK00 1-May Nov DK00 1-May Nov DK00 1-May Nov DK00 1-Jun Dec DK00 1-Jun Dec DK00 1-Jun Dec DK00 1-Jun Dec DK00 1-Jun Dec DK00 1-Jun Dec DK00 1-Jun Dec DK00 1-Jun Dec DK00 1-Jul Jan DK00 1-Jul Jan DK00 1-Jul Jan-2019 Back to Top Sodium Bicarbonate Injection, USP 8.4% (1 meq/ml); 50 meq/50 ml Single Dose Glass Fliptop Vial (NDC ) Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s

22 Page 18 of EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Feb Jul EV00 1-Mar Aug EV00 1-Mar Aug EV00 1-Mar Aug EV00 1-Mar Aug-2018

23 Page 19 of EV00 1-Mar Aug EV00 1-Mar Aug EV00 1-Mar Aug EV00 1-Mar Aug EV00 1-Mar Aug EV00 1-Mar Aug EV00 1-Apr Sep EV00 1-Apr Sep EV00 1-May Oct EV00 1-May Oct EV00 1-May Oct EV00 1-May Oct EV00 1-May Oct EV00 1-May Oct EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec EV00 1-Jul Dec-2018

24 Page 20 of EV00 1-Jul Dec-2018 Back to Top Sodium Bicarbonate Injection, USP 8.4% (1 meq/ml); 50 meq/50 ml Single Dose Glass Fliptop Vial (NDC ) LABELLED AS NOVAPLUS Product/ Lot Number Manufacturer s Original Expiry Date New Use Date (beyond manufacturer s 64083EV00 1-Apr Sep EV00 1-Apr Sep-2018 Back to Top More in Drug Shortages (/Drugs/DrugSafety/DrugShortages/default.htm) Drug Shortages: Additional News and Information (/Drugs/DrugSafety/DrugShortages/ucm htm) Frequently Asked Questions about Drug Shortages (/Drugs/DrugSafety/DrugShortages/ucm htm) Drug Shortages Infographic (/Drugs/DrugSafety/DrugShortages/ucm htm)