Products Affected - Description
Dexrazoxane injection, West-Ward (formerly Bedford product)
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
- West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired dexrazoxane injection from Bedford in July 2014. West-Ward is not actively marketing dexrazoxane injection at this time.
- 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
Biocodex USA has not yet started manufacturing Totect and the company cannot estimate when product will be available.
March 9, January 21, 2015; November 20, October 13, August 8, June 2, April 3, 2014; December 23, October 28, September 23, August 6 and 29, July 15 and 25, May 28, April 17, February 22 and 26; December 17, November 30, September 14, July 26, June 5, May 25, April 17 and 27, March 8, February 8, January 11 and 13; December 14, November, 30, 2011, University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.
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