[11 June 2013]
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)
Etomidate 2 mg/mL injection, Hospira
10 mL vial (NDC 00409-6695-01)
20 mL ampule (NDC 00409-8061-01)
20 mL vial (NDC 00409-6695-02)
20 mL Lifeshield syringes (NDC 00409-8060-29)
Etomidate 2 mg/mL injection, Mylan Institutional
20 mL vial (NDC 67457-0183-20)
Reason for the Shortage
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many multiple products for Bedford Laboratories, a division of Ben Venue.
- Hospira states etomidate injection is in short supply due to manufacturing delays.
- American Regent has etomidate injection on shortage due to raw material issues.
- Pfizer launched etomidate 10 mL and 20 mL vials in March, 2012.
- Sagent launched etomidate 10 mL and 20 mL vials in July, 2012 and states the shortage was due to demand exceeding supply.
Available Products
Etomidate 2 mg/mL injection, Hospira
10 mL ampule (NDC 00409-8062-01)
Etomidate 2 mg/mL injection, Pfizer
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)
Estimated Resupply Dates
- Bedford has etomidate 10 mL and 20 mL vials on back order and will not be manufactured until capacity permits.
- Hospira has Amidate 10 mL vials, 20 mL vials, and 20 mL Lifeshield syringes on back order and the company estimates a release date of mid-June 2013 for the 10 mL vials and late-June 2013 for the 20 mL vials and 20 mL Lifeshield syringes. The 20 mL ampules are on back order and the company cannot estimate a release date.
- American Regent has etomidate 10 mL and 20 mL vials on back order and the company cannot estimate a release date.
- Mylan Institutional has etomidate 20 mL vials available with short expiration dating (January 2014). Additional supplies are expected in late-April 2013.
Safety
Clinicians must take extra care to ensure safe use of etomidate when using different presentations than those normally stocked.
Related Shortages
Updated
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; December 19, 2011; December 6, 2011; October 26, 2011; August 31, 2011; August 3, 2011; July 6, 2011, University of Utah, Drug Information Service. Copyright 2013, 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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