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)
Reason for the Shortage
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 2014. 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.
- American Regent has recently upgraded their manufacturing plant. Product will become available in stages as production resumes.
- Hospira had buprenorphine on shortage due to API constraints and increased demand.
Buprenorphine 0.3 mg/mL injection, Hospira
1 mL Carpuject syringe (NDC 00409-2012-32)
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 the company cannot estimate a release date. Ben Venue manufactured buprenorphine injection for Bedford.
May 5, 2014; March 3, 2014; January 6, 2014; November 6, 2013; September 5, 2013; July 11, 2013; 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 2014, Drug Information Service, University of Utah, Salt Lake City, UT
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