Products Affected - Description
Dexrazoxane injection, Bedford
250 mg vial (NDC 55390-0014-02)
500 mg vial (NDC 55390-0060-02)
Totect Kit, Biocodex USA (formerly Apricus Pharmaceuticals and Topotarget USA)
500 mg vial, package of 10 (NDC 38423-0110-01 (only for extravasation injuries)
Reason for the Shortage
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 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.
- Biocodex USA acquired Totect from Apricus Pharmaceuticals in April 2013.
- Apricus Pharmaceuticals acquired Topotarget USA in late 2011.
- Topotarget worked with FDA to extend the expiration date of specific batch numbers of Totect to 36 months. Information regarding this extension and the batch numbers can be found in four Dear Healthcare Customer letters available online.
Dexrazoxane Injection, Mylan Institutional
250 mg vial (NDC 67457-0207-25)
500 mg vial (NDC 67457-0208-50)
Zinecard injection, Pfizer
250 mg vial (NDC 00013-8717-62)
500 mg vial (NDC 00013-8727-89)
Estimated Resupply Dates
Bedford has dexrazoxane 250 mg and 500 mg vials on back order and the company cannot estimate a release date. Ben Venue manufactured dexrazoxane for Bedford.
Biocodex USA has not yet started manufacturing Totect and the company cannot estimate when product will be available.
June 2, 2014; April 3, 2014; December 23, 2013; October 28, 2013; September 23, 2013; August 29, 2013; August 6, 2013; July 25, 2013; July 15, 2013; May 28, 2013; April 17, 2013; February 26, 2013; February 22, 2013; December 17, 2012; November 30, 2012; September 14, 2012; July 26, 2012; June 5, 2012; May 25, 2012; April 27, 2012; April 17, 2012; March 8, 2012; February 8, 2012; January 13, 2012; January 11, 2012; December 14, 2011; November, 30, 2011, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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