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Buprenorphine Injection

[20 May 2013]

Products Affected - Description

Buprenorphine 0.3 mg/mL injection, American Regent
1 mL vial (NDC 40042-0010-01) – discontinued 
1 mL vial (NDC 00517-0725-05)

Buprenorphine 0.3 mg/mL injection, Bedford
1 mL vial (NDC 55390-0100-10)

Buprenorphine 0.3 mg/mL injection, Hospira
1 mL Carpuject syringe (NDC 00409-2012-32)

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 multiple products for Bedford Laboratories, a division of Ben Venue.
  • American Regent has recently upgraded their manufacturing plant. Product will become available in stages as production resumes.
  • Hospira has buprenorphine on shortage due to API constraints and increased demand.

Available Products

Buprenex 0.3 mg/mL injection, Reckitt Benckiser
1 mL ampule (NDC 12496-0757-01)

Estimated Resupply Dates

  • American Regent has buprenorphine injection 0.3 mg/mL 1 mL vials on back order and the company cannot estimate a release date.
  • Bedford has buprenorphine injection on long-term back order and it will not be manufactured until capacity permits.
  • Hospira has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes on back order and the company cannot estimate a release date.

Related Shortages

Updated

May 20, 2013; April 11, 2013; March 11, 2013; February 13, 2013; January 7, 2013; November 7, 2012; September 27, 2012; August 13, 2012; July 3, 2012; May 14, 2012; April 4, 2012; February 8, 2012; December 14, 2011; November 21, 2011; October 18, 2011; September 16, 2011; August 25, 2011; July 22, 2011; June 30, 2011; May 23, 2011; April 29, 2011; April 7, 2011; February 16, 2011; December 21, 2010; November 12, 2010; October 8, 2010; September 24, 2010; September 10, 2010; September 3, 2010; August 18, 2010; July 20, 2010; July 15, 2010, 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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In Cooperation With

University of Utah & Novation
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