[06 February 2014]
Products Affected - Description
Sodium thiosulfate injection, American Regent
100 mg/mL, 10 mL vial (NDC 00517-1019-05)
250 mg/mL, 50 mL vial (NDC 00517-5019-01)
Reason for the Shortage
- American Regent has recently upgraded their manufacturing plant. Product will become available in stages as production resumes.
- Hope Pharmaceutical received FDA approval of their sodium thiosulfate product in February, 2012. Hope Pharmaceutical has the only FDA approved product of sodium thiosulfate.
- Hope also has Nithiodote available, a combination of sodium thiosulfate and sodium nitrite.
Sodium thiosulfate injection, Hope Pharmaceutical
250 mg/mL, 50 mL vial (NDC 60267-0705-50)
Estimated Resupply Dates
American Regent has sodium thiosulfate 100 mg/mL 10 mL vials and 250 mg/mL 50 mL vials on back order and the company cannot estimate a release date.
February 6, 2014; November 14, 2013; September 9, 2013; June 19, 2013; April 12, 2013; February 13, 2013; December 14, 2012; October 10, 2012; August 10, 2012; June 20, 2012; June 5, 2012; April 2, 2012; February 29, 2012; January 20, 2012; December 8, 2011; November 14, 2011; November 7, 2011; October 11, 2011; September 14, 2011; August 23, 2011; July 22, 2011; July 20, 2011; June 6, 2011; May 23, 2011; May 12, 2011; April 12, 2011, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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