[29 April 2013]
Products Affected - Description
Doxapram injection, Bedford
20 mg/mL, 20 mL vial (NDC 55390-0035-01)
Dopram injection, West-Ward
20 mg/mL, 20 mL vial (NDC 60977-0144-01) - NDC discontinued July, 2012
20 mg/mL, 20 mL vial (NDC 00641-6018-06)
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.
No presentations are available.
Estimated Resupply Dates
- Bedford has doxapram 20 mg/mL 20 mL vials for injection on back order and the company cannot estimate a release date.
- West-Ward has Dopram 20 mg/mL 20 mL vials for injection on back order and the company estimates a release date of July 2013.
April 29, 2013; February 22, 2013; January 16, 2013; December 10, 2012; November 9, 2012; September 19, 2012; July 18, 2012; April 18, 2012; February 22, 2012; January 24, 2012; December 28, 2011, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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