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etomidate Injection

[15 July 2014]

Products Affected - Description

Etomidate 2 mg/mL injection, American Regent
10 mL vial (NDC 00517-0780-10)
20 mL vial (NDC 00517-0781-10) 
 
Etomidate 2 mg/mL injection, Bedford
10 mL vial (NDC 55390-0762-10)
20 mL vial (NDC 55390-0763-20)
 
Amidate 2 mg/mL injection, Hospira
20 mL vial (NDC 00409-6695-02)

Etomidate 2 mg/mL injection, Mylan Institutional
10 mL vial (NDC 00069-0006-01)
20 mL vial (NDC 00069-0006-03)
Etomidate 2 mg/mL injection, Sagent
10 mL vial (NDC 25021-0674-10)
20 mL vial (NDC 25021-0674-20)

Reason for the Shortage

  • Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.1
  • Hospira states etomidate injection was in short supply due to manufacturing delays.
  • American Regent had temporarily suspended distribution of most drug products including etomidate injection in April, 2011.
  • American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
  • Mylan Institutional acquired etomidate injection from Pfizer on December 6, 2013. Mylan Institutional divested some presentations of etomidate injection to JHP Pharmaceuticals in April 2014.
  • Mylan recalled 10 lots of etomidate injection with the Pfizer label in February 2014. The recall was due to the presence of particulate matter and missing lot numbers and expiration dates on the vials.

Available Products

Amidate 2 mg/mL injection, Hospira
10 mL vial (NDC 00409-6695-01)
10 mL ampule (NDC 00409-8062-01)
20 mL ampule (NDC 00409-8061-01)
20 mL Lifeshield syringes (NDC 00409-8060-29)
 
Etomidate 2 mg/mL injection, JHP Pharmaceuticals
10 mL vial (NDC 67457-0183-10)
20 mL vial (NDC 42023-0170-10)

Estimated Resupply Dates

  • Bedford has etomidate 10 mL and 20 mL vials on back order and the company cannot estimate a release date. Ben Venue manufactured etomidate for Bedford.
  • American Regent has etomidate 10 mL and 20 mL vials on back order and the company cannot estimate a release date.
  • Hospira has Amidate 2 mg/mL 20 mL vials on back order and the company estimates a release date in mid-July 2014.
  • Mylan Institutional has etomidate 10 mL vials on back order and the company estimates a release date in early-September 2014. The 20 mL vials are temporarily unavailable and the company cannot estimate a release date.
    Sagent has etomidate 10 mL and 20 mL vials on back order and the company cannot estimate a return date as production has been suspended.
     

Safety

Clinicians must take extra care to ensure safe use of etomidate when using different presentations than those normally stocked.

Related Shortages

Updated

July 15, 2014; July 8, 2014; May 16, 2014; April 16, 2014; March 31, 2014; March 20, 2014; February 27, 2014; February 21, 2014; January 24, 2014; December 12, 2013; December 6, 2013; October 24, 2013; October 9 2013; September 3, 2013; July 25, 2013; June 27, 2013; June 11, 2013; May 28, 2013; April 23, 2013; April 9, 2013; April 3, 2013; March 8, 2013; February 25, 2013; February 13, 2013; January 31, 2013; January 29, 2013; January 22, 2013; January 11, 2013; December 14, 2012; December 7, 2012; November 19, 2012; November 5, 2012; October 4, 2012; September 14, 2012; August 7, 2012; July 25, 2012; July 19, 2012; June 18, 2012; May 29, 2012; May 2, 2012; April 3, 2012; March 21, 2012; March 14, 2012; March 2, 2012; February 27, 2012; February 14, 2012; February 7, 2012; January 31, 2012; January 27, 2012; January 3, 2012; July 6, 2011, University of Utah, Drug Information Service. Copyright 2014, University of Utah, Drug Information Service.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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