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Dexrazoxane Injection

[02 June 2014]

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.

Available Products

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.

Related Shortages

Updated

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.

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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