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Butorphanol Injection

[11 April 2013]

Products Affected - Description

Butorphanol injection, Bedford
1 mg/mL 1 mL vial (NDC 55390-0183-01)
2 mg/mL 1 mL vial (NDC 55390-0184-01)
2 mg/mL 2 mL vial (NDC 55390-0184-02)
2 mg/mL 10 mL vial (NDC 55390-0185-10)
 
Butorphanol injection, Hospira
2 mg/mL 1 mL vial (NDC 00409-1626-01)

Reason for the Shortage

  • Apotex discontinued butorphanol injection in 2008.
  • 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 multiple products for Bedford Laboratories, a division of Ben Venue.
  • Hospira states the shortage is due to increased demand.
  • West-Ward discontinued butorphanol injection in early 2012.
  • Sandoz discontinued Stadol injection in 2010.

Available Products

Butorphanol injection, Hospira
1 mg/mL 1 mL vial (NDC 00409-1623-01)
2 mg/mL 2 mL vial (NDC 00409-1626-02)

Estimated Resupply Dates

  • Bedford has all butorphanol presentations on long-term back order and the company cannot estimate a release date. Product will not be available again until capacity permits.
  • Hospira has butorphanol 2 mg/mL 1 mL vials on back order and the company estimates a release date in May, 2013.

Related Shortages

Updated

April 11, 2013; February 7, 2013; December 24, 2012; December 12, 2012; November 27, 2012; November 13, 2012; October 24, 2012; October 12, 2012; September 27, 2012; August 22, 2012; July 31, 2012; July 3, 2012; May 10, 2012; April 23, 2012; April 3, 2012; March 20, 2012; March 6, 2012; February 22, 2012; January 31, 2012; January 18, 2012; December 21, 2011; December 6, 2011; November 21, 2011; November 7, 2011; October 26, 2011; October 4, 2011; September 23, 2011; September 22, 2011; September 7, 2011; August 26, 2011; August 25, 2011; August 2, 2011; July 22, 2011; July 1, 2011; June 15, 2011; May 20, 2011; April 15, 2011, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.

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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