[7/02/2021] FDA is alerting civilian health care professionals and emergency responders of one (1) pralidoxime chloride and five (5) CANA (diazepam) auto-injector lots for which the “new use date” has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. An additional six (6) DuoDote lots are no longer useable and should be properly disposed of. Please refer to the table below for such updates.

For questions about DuoDote orders, stakeholders should contact Jonathan Daproza at Meridian Medical Technologies at [email protected] (443-259-7878) or MMT’s main email address ([email protected]) or phone number (443-259-7800).

[10/21/2020] FDA is alerting civilian health care professionals and emergency responders of one (1) pralidoxime chloride and five (5) CANA (diazepam) auto-injector lots for which the “new use date” has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. An additional one (1) DuoDote lot is no longer useable and should be properly disposed of. Please refer to the table below for such updates.

[06/01/2020] FDA is alerting civilian health care professionals and emergency responders of four (4) additional DuoDote lots that are no longer useable and should be properly disposed of. Please refer to the table below for such updates.

[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 [email protected] (443-259-7878) or MMT’s main email address ([email protected]) 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 [email protected] or Brooke Courtney at [email protected] 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 July 2, 2021).