[25 April 2013]
Products Affected - Description
Pentostatin 10 mg powder (NDC 55390-0244-01), Bedford
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 multiple products for Bedford Laboratories, a division of Ben Venue.
Available Products
Nipent 10 mg powder (NDC 00409-0801-01), Hospira
Estimated Resupply Dates
Bedford has pentostatin injection on back order and the company cannot estimate a release date. Production will resume once capacity permits.
Related Shortages
Updated
April 25, 2013; February 8, 2013; December 19, 2012; October 9, 2012; July 25, 2012; June 20, 2012; April 23, 2012; March 20, 2012; March 5, 2012; February 28, 2012; January 24, 2012; December 21, 2011, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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