[15 March 2013]
Products Affected - Description
Terbutaline sulfate injection, 1 mg/mL, Akorn
1 mL ampule (NDC 17478-0933-01) - discontinued
Terbutaline sulfate injection, 1 mg/mL, Bedford
1 mL vial, package of 10 (NDC 55390-0101-10)
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.
- Akorn has discontinued terbutaline injection.
Terbutaline sulfate injection, 1 mg/mL, APP
1 mL vial, package of 25 (NDC 63323-0665-01)
Terbutaline sulfate injection, 1 mg/mL, West-Ward
1 mL vial, package of 10 (NDC 00143-9746-10)
Estimated Resupply Dates
Bedford has terbutaline 1 mg/mL1 mL vials on long-term back order and will not be manufactured until capacity permits.
March 15, 2013; December 18, 2012; September 19, 2012; July 2, 2012; June 13, 2012; May 2, 2012; March 28, 2012; February 17, 2012; December 14, 2011; November 9, 2011; September 30, 2011; August 22, 2011; July 28, 2011; July 1, 2011, University of Utah, Drug Information Service. Copyright 2013, University of Utah, Drug Information Service.
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