[17 April 2013]
Products Affected - Description
Dexrazoxane injection, Bedford
250 mg vial (NDC 55390-0014-02)
500 mg vial (NDC 55390-0060-02)
Totect Kit, Apricus Pharmaceuticals (formerly Topotarget USA)
500 mg vial, package of 10 (NDC 38423-0110-01) - only for extravasation injuries
Reason for the Shortage
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many multiple products for Bedford Laboratories, a division of Ben Venue.
- Mylan Institutional states the reason for the shortage was that demand exceeded supply due to market conditions.
- Apricus Pharmaceuticals acquired Topotarget USA in late 2011.
- Apricus could not provide a reason for the shortage.
- 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.
Zinecard injection, Pfizer
250 mg vial (NDC 00013-8717-62)
500 mg vial (NDC 00013-8727-89)
Dexrazoxane Injection, Mylan Institutional
250 mg vial (NDC 67457-0207-25)
500 mg vial (NDC 67457-0208-50)
Estimated Resupply Dates
- Bedford has dexrazoxane 250 mg and 500 mg vials on back order and the company cannot estimate a release date.
- Apricus Pharmaceuticals has halted manufacturing of Totect and the company cannot estimate when product will be available again.
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 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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