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U.S. Department of Health and Human Services

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

Certain lots of DuoDote can be used for two years beyond the labeled expiration date.

  

[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. 

[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 DateNew 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

 


 

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: