Epinephrine ampules withdrawn

The following was posted at the FDA website:

“American Regent Initiates Nationwide Voluntary Recall of Epinephrine
Injection, USP, 1:1000, 1mL Ampules Lot #1395 Due to Discoloration and
Small Visible. Regent is conducting a nationwide voluntary recall to the
Retail/Hospital level of the following product: Epinephrine Injection, USP,
1:1000, 1 mL Ampules NDC #0517-1071-25 Lot #1395, Exp Date: July 2012”

If you are using ampules check the dates and lot numbers listed above.

This is just another reminder that epinephrine shoud be visually inspected before use.  It should be clear with no dislcoloration and free of any particulates.  The manufacturer’s recommended storage temperatures are between 15° and 25° C (59º and 77º F) with no freezing (Lexicomp database).  There is literature to suggest that those extremes can be pushed and that expiration dates are not set in stoneFreezing and then thawing is not a good idea for liquids in general but I could find nothing specific about epinphrine.  Storing out of direct sunlight is also felt to be a good idea. 


Use epinephrine that is up-to-date, clear without color, and free of particulates.  Storing in a hot glove compartment for hours or a few days is most likely okay as long as the prior conditions are met.  Freeze/thaw is not so clear.  An expirated EpiPen will be degraded but still helpful if clear/colorless and particulate free.

If you take any medications into the field, consider the following:

1.  Store them properly

2.  Check expiration dates and replace expired medications with fresh replacements before leaving

3.  Periodically check the condition of  medications and their packaging. 


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