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  1. Drug Safety and Availability

FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies

CANA (diazepam) and Pralidoxime Chloride auto-injectors manufactured by Meridian Medical Technologies nearing or beyond their labeled or extended expiration dates should be retained until further guidance is provided by FDA. Please refer to the posting and table below for instructions about the usability of certain DuoDote, AtroPen (atropine), and morphine sulfate lots.

[01/10/2020] FDA is alerting civilian health care professionals and emergency responders of two (2) additional DuoDote lots that are no longer useable and should be properly disposed of. Please refer to the table below for such updates.

[11/18/2019] This posting and FDA’s November 18, 2019, memorandum replace FDA’s March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders of extensions of the labeled expiration dates of certain lots of auto-injectors for use during nerve agent emergencies.

Since September 2013, FDA has helped to support civilian emergency response stakeholder readiness for a chemical nerve agent emergency by using scientific data to extend the expiration dating of certain lots of DuoDote and other auto-injector products manufactured by Meridian Medical Technologies (MMT) due to supply disruptions.

Based on available scientific data, lots of DuoDote auto-injectors in the table below are not eligible for additional expiration dating extensions beyond the new use dates posted. As FDA has stated since 2014, if MMT provides replacement DuoDote product to stakeholders during the posted extension period, then it is expected that stakeholders holding the DuoDote lots in the following table will replace and properly dispose of them as soon as possible. MMT has informed FDA that it has fulfilled its commitment to replace DuoDote auto-injector units in the field with a labeled expiration date of May 2013 to October 2016.

However, if stakeholders have not received replacement DuoDote product from MMT and still hold lots in the following table, then they may continue to use the new use dates provided for those lots in the table below until the product is replaced or reaches the end of its new use date, after which it should be properly disposed of.  

In addition, FDA has received stakeholder inquiries about expiration dating extensions for certain lots of DuoDote product that they have received from MMT since 2015 (i.e., with a labeled expiration date of February 2019 or later) and are not included in the table below. The DuoDote expiration dating extensions FDA previously issued were in response to supply disruptions. Because DuoDote manufacturing has resumed, expiration dating extensions of lots with a labeled expiration date of February 2019 or later are not warranted at this time.

For questions about DuoDote orders, stakeholders should contact Jonathan Daproza at Meridian Medical Technologies at jonathan.daproza@meridianmt.com (443-259-7878) or MMT’s main email address (info@meridianmt.com) or phone number (443-259-7800).

In addition, the table below provides an updated list of new use dates for certain CANA (diazepam) and pralidoxime chloride auto-injector lots for nerve agent emergency use. FDA is not requiring or recommending that such identified lots be relabeled with their new use dates.  Also, for certain CANA (diazepam) lots for which the “new use date” has already passed, FDA recommends that stakeholders retain the lots in the event that additional scientific information becomes available to support additional extensions. If additional scientific information does not support further extensions for the specific lot number, FDA will provide a future update.

The table below also includes certain lots of AtroPen (atropine), DuoDote, and morphine sulfate auto-injectors that are no longer eligible for expiry dating extensions and should be properly disposed of.

Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this update. Department of Defense (DoD) components should continue to direct any auto-injector expiration dating and disposal questions to the DoD Shelf-Life Extension Program (SLEP) Manager.

 

Status of the use of AtroPen (atropine), CANA (diazepam), DuoDote, and Pralidoxime Chloride auto-injector lots for nerve agent emergencies beyond the manufacturer’s original labeled expiration date (updated January 10, 2020).

Product/
Lot Number

Manufacturer’s Original 
Expiry Date

New Use Date 
(beyond manufacturer’s original expiry date)

 

 

 

AtroPen (atropine)*

2PE729*

September 30, 2015*

* Previously, FDA provided extended expiry dates for the lots of AtroPen (atropine) auto-injectors marked with an asterisk (*). However, because no further expiry dating extensions of these lots are possible under this memorandum, these lots are no longer useable and should be properly disposed of.

 

 

 

 

 

 

 

 

 

 

                    

2PF298*

September 30, 2015*

OSM286*

April 30, 2013*

OSL357*

May 31, 2013*

OSL358*

May 31, 2013*

OSM617*

July 31, 2013*

OSL619*

July 31, 2013*

OSL620*

July 31, 2013*

0SL616*

November 30, 2013*

0SM801*

November 30, 2013*

1PE860*

November 30, 2014*

1PF784*

October 31, 2014*

1PG783*

October 31, 2014*

2PE127*

January 31, 2015*

2PG115*

January 31, 2015*

2PG201*

January 31, 2015*

0S4468*

July 31, 2015*

0S4637*

July 31, 2015*

CANA (diazepam)*

8D1037*

May 31, 2013*

* For CANA (diazepam) lots in this table for which the “new use date” has already passed, FDA recommends that stakeholders retain such lots in the event that FDA authorizes additional extensions.

8D1038*

May 31, 2013*

8D1039*

May 31, 2013*

8D1366*

May 31, 2013*

8D1367*

May 31, 2013*

8D1368*

May 31, 2013*

9D1347

August 31, 2014

August 31, 2020

9D1666

July 31, 2014

July 31, 2020

9D1667

July 31, 2014

July 31, 2020

9DB731

August 31, 2014

August 31, 2020

9DY732

August 31, 2014

August 31, 2020

0D1093

December 31, 2014

December 31, 2020

0D1264

March 31, 2015

March 31, 2021

0D1460

April 30, 2015

April 30, 2021

0D1461

April 30, 2015

April 30, 2021

0D1462

April 30, 2015

April 30, 2021

1D1349

April 30, 2016

April 30, 2022

1D1520

May 31, 2016

May 31, 2022

1D1562

June 30, 2016

June 30, 2022

2D2698

August 31, 2017

August 31, 2023

2D2699

August 31, 2017

August 31, 2023

2D2700

August 31, 2017

August 31, 2023

2D2765

October 31, 2017

October 31, 2023

DuoDote*

8AE795*

October 31, 2012*

* Previously, FDA provided extended expiry dates for the lots of DuoDote auto-injectors marked with an asterisk (*). However, because no further expiry dating extensions of these lots are possible under this memorandum, these lots are no longer useable and should be properly disposed of.

9AE306*

January 31, 2013*

9AE307*

March 31, 2013*

9AE356*

March 31, 2013*

9AE545*

March 31, 2013*

9AE548*

May 31, 2013*

9AE636*

May 31, 2013*

9AE645*

June 30, 2013*

9AE835*

September 30, 2013*

0AE158*

December 31, 2013*

0AE159*

December 31, 2013*

0AE287

February 28, 2014

February 29, 2020

0AE458

April 30, 2014

April 30, 2020

0AE500

May 31, 2014

May 31, 2020

0AE501

May 31, 2014

May 31, 2020

0AE792

September 30, 2014

September 30, 2020

1AE200

December 31, 2014

December 31, 2020

1AE201

February 28, 2015

February 28, 2021

1AE406

April 30, 2015

April 30, 2021

1AE502

March 31, 2015

March 31, 2021

1AE515

May 31, 2015

May 31, 2021

1AE516

June 30, 2015

June 30, 2021

1AE701

August 31, 2015

August 31, 2021

1AE702

September 30, 2015

September 30, 2021

1AE703

September 30, 2015

September 30, 2021

2AE752

October 31, 2016

October 31, 2022

Morphine Sulfate*

2HD060*

February 28, 2014*

* Previously, FDA provided extended expiry dates for the lots of morphine sulfate auto-injectors marked with an asterisk (*). However, because no further expiry dating extensions of these lots are possible under this memorandum, these lots are no longer useable and should be properly disposed of.

2HD116*

February 28, 2014*

2HD202*

February 28, 2014*

2HJ452*

July 31, 2014*

2HJ686*

August 31, 2014*

2HJ687*

August 31, 2014*

2HJ688*

August 31, 2014*

2HJ689*

August 31, 2014*

Pralidoxime Chloride

9TF088

March 31, 2014

March 31, 2020

0TF265

March 31, 2015

March 31, 2021

1TF533

August 31, 2016

August 31, 2021

[03/23/2018] FDA is alerting civilian health care professionals and emergency responders of additional AtroPen (atropine) lots that are no longer useable and should be properly disposed of. Please refer to the table below for such updates.

[7/05/2017] FDA is alerting civilian health care professionals and emergency responders of updated dates through which certain lots of AtroPen (atropine), CANA (diazepam), DuoDote, and pralidoxime chloride auto-injectors, manufactured by Meridian Medical Technologies, 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.

This posting and FDA’s June 26, 2017, memorandum replace FDA’s March 2, 2016, memorandum and all previous FDA web postings notifying health care professionals and emergency responders of extensions of the labeled expiration dates of certain lots of auto-injectors. The table below is an updated list of AtroPen (atropine), CANA (diazepam), DuoDote, and pralidoxime chloride auto-injector lots and new use dates for nerve agent emergency use. The list also includes certain lots of AtroPen (atropine) and morphine sulfate auto-injectors that are no longer eligible for expiry dating extensions and should be properly disposed of.

FDA is not requiring or recommending that the identified lots in the following table be relabeled with their new use dates. However, if replacement auto-injector product becomes available during the extension period, then it is expected that the lots in this updated table will be replaced and properly disposed of as soon as possible. Please note that because no further expiry dating extensions are possible for certain lots of AtroPen (atropine) and morphine sulfate identified in this table, such lots are no longer useable and should be properly disposed of.

Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this table. Department of Defense (DoD) components should direct any auto-injector expiry dating and disposal questions to the DoD Shelf-Life Extension Program (SLEP) Program Manager.

AtroPen (atropine), CANA (diazepam), DuoDote, and Pralidoxime Chloride auto-injector lots eligible for use beyond the manufacturer’s labeled expiration date (updated March 23, 2018).

 

Product/
Lot Number

Manufacturer’s Original
Expiry Date

New Use Date
(beyond manufacturer’s original expiry date)

AtroPen (atropine)

2PE729

September 30, 2015

September 30, 2018

2PF298

September 30, 2015

September 30, 2018

OSM286*

April 30, 2013*

* Previously, FDA provided extended expiry dates for the lots of AtroPen (atropine) auto-injectors marked with an asterisk (*). However, because no further expiry dating extensions of these lots are possible under this memorandum, these lots are no longer useable and should be properly disposed of.

OSL357*

May 31, 2013*

OSL358*

May 31, 2013*

OSM617*

July 31, 2013*

OSL619*

July 31, 2013*

OSL620*

July 31, 2013*

0SL616*

November 30, 2013*

0SM801*

November 30, 2013*

1PE860*

November 30, 2014*

1PF784*

October 31, 2014*

1PG783*

October 31, 2014*

2PE127*

January 31, 2015*

2PG115*

January 31, 2015*

2PG201*

January 31, 2015*

0S4468*

July 31, 2015*

0S4637*

July 31, 2015*

CANA
(diazepam)

8D1037

May 31, 2013

May 31, 2018

8D1038

May 31, 2013

May 31, 2018

8D1039

May 31, 2013

May 31, 2018

8D1366

May 31, 2013

May 31, 2018

8D1367

May 31, 2013

May 31, 2018

8D1368

May 31, 2013

May 31, 2018

9D1347

August 31, 2014

August 31, 2019

9D1666

July 31, 2014

July 31, 2019

9D1667

July 31, 2014

July 31, 2019

9DB731

August 31, 2014

August 31, 2019

9DY732

August 31, 2014

August 31, 2019

0D1093

December 31, 2014

December 31, 2019

0D1264

March 31, 2015

March 31, 2020

0D1460

April 30, 2015

April 30, 2020

0D1461

April 30, 2015

April 30, 2020

0D1462

April 30, 2015

April 30, 2020

1D1349

April 30, 2016

April 30, 2021

1D1520

May 31, 2016

May 31, 2021

1D1562

June 30, 2016

June 30, 2021

2D2698

August 31, 2017

August 31, 2022

2D2699

August 31, 2017

August 31, 2022

2D2700

August 31, 2017

August 31, 2022

2D2765

October 31, 2017

October 31, 2022

DuoDote

8AE795

October 31, 2012

October 31, 2018

9AE306

January 31, 2013

January 31, 2019

9AE307

March 31, 2013

March 31, 2019

9AE356

March 31, 2013

March 31, 2019

9AE545

March 31, 2013

March 31, 2019

9AE548

May 31, 2013

May 31, 2019

9AE636

May 31, 2013

May 31, 2019

9AE645

June 30, 2013

June 30, 2019

9AE835

September 30, 2013

September 30, 2019

0AE158

December 31, 2013

December 31, 2019

0AE159

December 31, 2013

December 31, 2019

0AE287

February 28, 2014

February 28, 2020

0AE458

April 30, 2014

April 30, 2020

0AE500

May 31, 2014

May 31, 2020

0AE501

May 31, 2014

May 31, 2020

0AE792

September 30, 2014

September 30, 2020

1AE200

December 31, 2014

December 31, 2020

1AE201

February 28, 2015

February 28, 2021

1AE406

April 30, 2015

April 30, 2021

1AE502

March 30, 2015

March 30, 2021

1AE515

May 31, 2015

May 31, 2021

1AE516

June 30, 2015

June 30, 2021

1AE701

August 31, 2015

August 31, 2021

1AE702

September 30, 2015

September 30, 2021

1AE703

September 30, 2015

September 30, 2021

2AE752

October 31, 2016

October 31, 2022

Morphine Sulfate*

2HD060*

February 28, 2014*

* Previously, FDA provided extended expiry dates for the lots of morphine sulfate auto-injectors marked with an asterisk (*). However, because no further expiry dating extensions of these lots are possible under this memorandum, these lots are no longer useable and should be properly disposed of.

2HD116*

February 28, 2014*

2HD202*

February 28, 2014*

2HJ452*

July 31, 2014*

2HJ686*

August 31, 2014*

2HJ687*

August 31, 2014*

2HJ688*

August 31, 2014*

2HJ689*

August 31, 2014*

Pralidoxime Chloride

9TF088

March 31, 2014

March 31, 2019

0TF265

March 31, 2015

March 31, 2020

1TF533

August 31, 2016

August 31, 2021

1The following AtroPen (atropine) lots (with the original labeled expiry dates listed) also are no longer useable and should be properly disposed of: OSL357 (May 31, 2013); OSL358 (May 31, 2013); OSL619 (July 31, 2013); OSL620 (July 31, 2013); OSM286 (April 30, 2013); and OSM617 (July 31, 2013).

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[04/15/2016] FDA is alerting health care professionals and emergency responders of updated dates through which certain lots of AtroPen (atropine), CANA (diazepam), morphine sulfate, and pralidoxime chloride auto-injectors, manufactured by Meridian Medical Technologies, 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.

This posting and FDA’s March 2, 2016, memorandum update and replace FDA’s October 2, 2014, memorandum, which notified health care professionals and emergency responders of a one-year extension of the labeled expiration dates of certain lots of these auto-injectors. The table below is an updated list of AtroPen (atropine), CANA (diazepam), morphine sulfate, and pralidoxime chloride auto-injector lots and new use dates.

The new table also includes the DuoDote lots listed in FDA’s March 27, 2015, web posting. This is for easier stakeholder reference so that all auto-injector lots (i.e., for AtroPen (atropine), CANA (diazepam), morphine sulfate, pralidoxime chloride, and DuoDote) and their new use dates are listed in a single table.

FDA is not requiring or recommending that the identified lots in the following table be relabeled with their new use dates. However, if replacement auto-injector product becomes available during the extension period, then it is expected that the lots in this updated table will be replaced and properly disposed of as soon as possible.

Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this table.

AtroPen, CANA, DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injector lots eligible for use beyond the manufacturer’s labeled expiration date (updated April 15, 2016).

Product/
Lot Number

Manufacturer’s Original         
Expiry Date

New Use Date
(beyond manufacturer’s original expiry date)

AtroPen (atropine)

 

 

0SL616

November 30, 2013

May 31, 2015

0SM801

November 30, 2013

May 31, 2015

1PE860

November 30, 2014

November 30, 2016

1PF784

October 31, 2014

October 31, 2016

1PG783

October 31, 2014

October 31, 2016

2PE127

January 31, 2015

January 31, 2017

2PG115

January 31, 2015

January 31, 2017

2PG201

January 31, 2015

January 31, 2017

0S4468

July 31, 2015

January 31, 2017

0S4637

July 31, 2015

January 31, 2017

CANA
(diazepam)

 

 

9D1347

August 31, 2014

August 31, 2016

9D1666

July 31, 2014

July 31, 2016

9D1667

July 31, 2014

July 31, 2016

9DB731

August 31, 2014

August 31, 2016

9DY732

August 31, 2014

August 31, 2016

0D1093

December 31, 2014

December 31, 2016

0D1264

March 31, 2015

March 31, 2017

0D1460

April 30, 2015

April 30, 2017

0D1461

April 30, 2015

April 30, 2017

0D1462

April 30, 2015

April 30, 2017

DuoDote

 

 

8AE795

October 31, 2012

October 31, 2015

9AE306

January 31, 2013

January 31, 2016

9AE307

March 31, 2013

March 31, 2016

9AE356

March 31, 2013

March 31, 2016

9AE545

March 31, 2013

March 31, 2016

9AE548

May 31, 2013

May 31, 2016

9AE636

May 31, 2013

May 31, 2016

9AE645

June 30, 2013

June 30, 2016

9AE835

September 30, 2013

September 30, 2016

0AE158

December 31, 2013

December 31, 2016

0AE159

December 31, 2013

December 31, 2016

0AE287

February 28, 2014

February 28, 2017

0AE458

April 30, 2014

April 30, 2017

0AE500

May 31, 2014

May 31, 2017

0AE501

May 31, 2014

May 31, 2017

0AE792

September 30, 2014

September 30, 2017

1AE200

December 31, 2014

December 31, 2017

1AE201

February 28, 2015

February 28, 2018

1AE406

April 30, 2015

April 30, 2018

1AE502

March 30, 2015

March 30, 2018

1AE515

May 31, 2015

May 31, 2018

1AE516

June 30, 2015

June 30, 2018

1AE701

August 31, 2015

August 31, 2018

1AE702

September 30, 2015

September 30, 2018

1AE703

September 30, 2015

September 30, 2018

2AE752

October 31, 2016

October 31, 2019

Morphine Sulfate

 

 

2HD060

February 28, 2014

February 29, 2016

2HD116

February 28, 2014

February 29, 2016

2HD202

February 28, 2014

February 29, 2016

2HJ452

July 31, 2014

July 31, 2016

2HJ686

August 31, 2014

August 31, 2016

2HJ687

August 31, 2014

August 31, 2016

2HJ688

August 31, 2014

August 31, 2016

2HJ689

August 31, 2014

August 31, 2016

Pralidoxime Chloride

 

 

9TF088

March 31, 2014

March 31, 2016

0TF265

March 31, 2015

March 31, 2017

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[03/27/2015] FDA is alerting health care professionals and emergency responders of updated dates through which DuoDote auto-injectors, manufactured by Meridian Medical Technologies, 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.

This posting updates FDA’s May 13, 2014 alert, which notified health care professionals and emergency responders of a two-year extension of the labeled expiration dates of certain lots of DuoDote auto-injectors. The table below is an updated list of DuoDote auto-injector lots and new use dates. This new list, which replaces previously posted lists, includes each of the lots listed in FDA’s May 13, 2014 posting, March 28, 2014 postingDecember 24, 2013 posting, and September 5, 2013 memorandum, as well as 10 new lots.

FDA is not requiring or recommending that the identified lots in the following table be relabeled with their new use dates. However, if replacement DuoDote product becomes available during the extension period, then it is expected that the DuoDote lots in this updated table will be replaced and properly disposed of as soon as possible.

Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this table.

DuoDote auto-injector lots eligible for use beyond the manufacturer’s labeled expiration date (updated March 27, 2015). 

Lot Number

 Manufacturer’s Original Expiry Date

 New Use Date

8AE795

October 31, 2012

October 31, 2015

9AE306

January 31, 2013

January 31, 2016

9AE307

March 31, 2013

March 31, 2016

9AE356

March 31, 2013

March 31, 2016

9AE545

March 31, 2013

March 31, 2016

9AE548

May 31, 2013

May 31, 2016

9AE636

May 31, 2013

May 31, 2016

9AE645

June 30, 2013

June 30, 2016

9AE835

September 30, 2013

September 30, 2016

0AE158

December 31, 2013

December 31, 2016

0AE159

December 31, 2013

December 31, 2016

0AE287

February 28, 2014

February 28, 2017

0AE458

April 30, 2014

April 30, 2017

0AE500

May 31, 2014

May 31, 2017

0AE501

May 31, 2014

May 31, 2017

0AE792

September 30, 2014

September 30, 2017

1AE200

December 31, 2014

December 31, 2017

1AE201

February 28, 2015

February 28, 2018

1AE406

April 30, 2015

April 30, 2018

1AE502

March 30, 2015

March 30, 2018

1AE515

May 31, 2015

May 31, 2018

1AE516

June 30, 2015

June 30, 2018

1AE701

August 31, 2015

August 31, 2018

1AE702

September 30, 2015

September 30, 2018

1AE703

September 30, 2015

September 30, 2018

2AE752

October 31, 2016

October 31, 2019

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[10/24/2014] FDA is alerting health care professionals and emergency responders that specific lots of AtroPen (atropine), CANA (diazepam), morphine sulfate, and pralidoxime chloride auto-injectors manufactured by Meridian Medical Technologies can be used for up to one additional year beyond the manufacturer’s labeled expiration date.

This notice is in follow up to FDA’s November 22, 2013, statement, and will help mitigate potential shortages of these medically necessary drugs.

To help assure patient safety, products should have been − and should continue to be − stored under the manufacturer’s labeled storage conditions.

The list of lots of these four products that can be used for up to an additional year beyond the manufacturer’s labeled expiration date can be found in FDA’s October 2, 2014, memorandum.

Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions.  

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FDA further extends expiration dates of DuoDote auto-injector lots manufactured by Meridian Medical Technologies

[05/13/2014] FDA is alerting health care professionals and emergency responders that two more lots (8AE795 and 9AE306) of DuoDote auto-injectors, manufactured by Meridian Medical Technologies, can be used for up to two years beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored under their labeled storage conditions.

This updates FDA’s March 28, 2014 alert, which notified health care professionals and emergency responders of a two-year extension of the labeled expiration date of certain lots of DuoDote auto-injectors. The table below is an updated list of DuoDote auto-injector lots and new use dates. This new list includes each of the lots listed in FDA’s March 28, 2014, posting and December 24, 2013, posting, and September 5, 2013, memorandum; and also includes the two new lots.

DuoDote auto-injector lots eligible for use up to two years beyond the manufacturer’s labeled expiration date (updated May 13, 2014). 

Lot Number
Manufacturer’s Original Expiry Date
New Use Date (up to 2 years beyond manufacturer’s original expiry date)
8AE795 October 31, 2012 October 31, 2014
9AE306 January 31, 2013 January 31, 2015
9AE307
March 31, 2013
March 31, 2015
9AE356
March 31, 2013
March 31, 2015
9AE545
March 31, 2013
March 31, 2015
9AE548
May 31, 2013
May 31, 2015
9AE636
May 31, 2013
May 31, 2015
9AE645
June 30, 2013
June 30, 2015
9AE835
September 30, 2013
September 30, 2015
0AE158
December 31, 2013
December 31, 2015
0AE159
December 31, 2013
December 31, 2015
0AE287
February 28, 2014
February 28, 2016
0AE458
April 30, 2014
April 30, 2016
0AE500
May 31, 2014
May 31, 2016
0AE501
May 31, 2014
May 31, 2016
0AE792
September 30, 2014
September 30, 2016
If replacement DuoDote product becomes available during the two-year extension period, then it is expected that the DuoDote lots in this updated table will be replaced and properly disposed of as soon as possible.

FDA is not requiring or recommending that the identified lots be relabeled with the new use date. Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this table. 

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[03/28/2014] FDA is alerting health care professionals and emergency responders that certain lots of DuoDote auto-injectors, manufactured by Meridian Medical Technologies, can be used for up to two years beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored under their labeled storage conditions.

This updates FDA’s December 2013 alert, which notified health care professionals and emergency responders of a one-year extension of the labeled expiration date of certain lots of DuoDote auto-injectors. The table below is an updated list of DuoDote auto-injector lots and new use dates. This new list includes each of the lots listed in FDA’s September 5, 2013, DuoDote memorandum and December 24, 2013, posting, and also includes one new lot, 0AE792.

DuoDote auto-injector lots eligible for use up to two years beyond the manufacturer’s labeled expiration date (updated March 28, 2014).

Lot Number
Manufacturer’s Original Expiry Date
New Use Date (up to 2 years beyond manufacturer’s original expiry date)
9AE307
March 31, 2013
March 31, 2015
9AE356
March 31, 2013
March 31, 2015
9AE545
March 31, 2013
March 31, 2015
9AE548
May 31, 2013
May 31, 2015
9AE636
May 31, 2013
May 31, 2015
9AE645
June 30, 2013
June 30, 2015
9AE835
September 30, 2013
September 30, 2015
0AE158
December 31, 2013
December 31, 2015
0AE159
December 31, 2013
December 31, 2015
0AE287
February 28, 2014
February 28, 2016
0AE458
April 30, 2014
April 30, 2016
0AE500
May 31, 2014
May 31, 2016
0AE501
May 31, 2014
May 31, 2016
0AE792
September 30, 2014
September 30, 2016

If replacement DuoDote product becomes available during the two-year extension period, then it is expected that the DuoDote lots in this updated table will be replaced and properly disposed of as soon as possible.

FDA is not requiring or recommending that the identified lots be relabeled with the new use date. Please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov with questions regarding this table.

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[12/24/2013] FDA is now alerting health care providers and emergency responders of more lots of DuoDote auto-injectors, manufactured by Meridian Medical Technologies, a Pfizer, Inc., company, that can be used for up to an additional year past the manufacturer’s labeled expiration date.  To help assure patient safety, products should have been stored under labeled storage conditions.

In follow up to the November 22, 2013, FDA drug safety statement, the following table is a cumulative list of DuoDote lots listed in FDA’s September 5, 2013, memorandum and additional lots identified by FDA in December 2013 to further address stakeholder needs.

For questions related to this table, please contact Brad Leissa at brad.leissa@fda.hhs.gov or Brooke Courtney at brooke.courtney@fda.hhs.gov.

DuoDote auto-injector lots eligible for use up to one year beyond the manufacturer’s labeled expiration date (updated December 24, 2013)

  Manufacturer’s Original Expiry Date New Use Date (up to 1 year beyond manufacturer’s original expiry date)
9AE307 March 31, 2013 March 31, 2014
9AE356 March 31, 2013 March 31, 2014
9AE545 March 31, 2013 March 31, 2014
9AE548 May 31, 2013 May 31, 2014
9AE636 May 31, 2013 May 31, 2014
9AE645 June 30, 2013 June 30, 2014
9AE835 September 30, 2013 September 30, 2014
0AE158 December 31, 2013 December 31, 2014
0AE159 December 31, 2013 December 31, 2014
0AE287 February 28, 2014 February 28, 2015
0AE458 April 30, 2014 April 30, 2015
0AE500 May 31, 2014 May 31, 2015
0AE501 May 31, 2014 May 31, 2015
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FDA alerts health care providers and emergency responders of a potential extension of expiration dates for certain auto-injectors manufactured by Meridian Medical Technologies

[11/22/2013] The U.S. Food and Drug Administration is aware of a disruption in supply to health care providers and emergency response personnel of Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors manufactured by Meridian Medical Technologies, a Pfizer Inc. company. FDA and Meridian are working together to resolve the disruption as quickly as possible, but it is unclear how long this disruption may persist.

As communicated on September 5, 2013 (PDF - 39KB), FDA concluded that it was scientifically supported that certain lots of DuoDote can be used for an additional year beyond the manufacturer’s original labeled expiration date. FDA is continuing to assess whether these identified lots of DuoDote can receive further expiration date extensions if needed, and whether additional lots of DuoDote that were not listed in FDA’s September 5, 2013, memo can have their expiration date extended.

FDA is currently reviewing data for the potential use of Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors beyond their labeled expiration dates in order to mitigate any potential shortages of these medically necessary drugs. Products nearing or beyond their labeled expiration dates should be retained until further guidance is provided by FDA.

What health care providers and emergency response personnel should know:

  • Health care providers and emergency response personnel who have any of the auto-injectors manufactured by Meridian identified above that are nearing or beyond the labeled expiration date should retain the products until FDA is able to provide additional information regarding the continued use of these products.

  • Due to medical necessity and potential drug shortages, FDA is reviewing data for the potential use of these products beyond their labeled expiration dates.

  • FDA will provide additional information about use of these products beyond the labeled expiration date in the coming weeks. Until FDA provides additional information, these expired auto-injectors may be used for patient care under emergency situations when no other product is available.

  • Health care providers and emergency response personnel should maintain and monitor these products under the storage conditions described in the product labeling information.

  • FDA continues to work with Meridian to resolve manufacturing issues.

  • It is unclear at this time when Meridian will have additional inventory of these auto-injectors available. 

If health care providers and emergency response personnel have additional questions about these auto-injectors, please contact Meridian’s customer service office at 1-866-478-6277.

FDA asks health care providers and consumers to report any adverse events that are associated with the use of any of these products to either Pfizer Safety (1-800-438-1985) or to the FDA’s MedWatch Adverse Event Reporting program by:

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