[09 April 2013]
Products Affected - Description
Mesna 100 mg/mL Injection, Bedford
10 mL vial, 1 count (NDC 55390-0045-01)
Mesna 100 mg/mL Injection, Teva
10 mL vial, 10 count (NDC 00703-4805-03)
Reason for the Shortage
- Teva has a shortage of mesna injection due to manufacturing delays.
- Sagent could not provide a 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 products for Bedford Laboratories, a division of Ben Venue.
Available Products
Mesna 100 mg/mL injection, APP
10 mL vial, 1 count (NDC 63323-0773-11)
10 mL vial, 10 count (NDC 63323-0773-10)
Mesna 100 mg/mL Injection, Baxter
10 mL vial, 1 count (NDC 10019-0933-01)
10 mL vial, 10 count (NDC 10019-0933-02)
Mesnex 100 mg/mL Injection, Baxter
10 mL vial, 1 count (NDC 00338-1305-01)
10 mL vial, 10 count (NDC 00338-1305-03)
Mesna 100 mg/mL Injection, Mylan Institutional
10 mL vial, 10 count (NDC 67457-0148-10)
Mesna 100 mg/mL injection, Sagent
10 mL vials, 1 count (NDC 25021-0201-10)
10 mL vials, 10 count (NDC 25021-0201-11)
Estimated Resupply Dates
- Bedford has mesna injection 10 mL vials in single count presentations on long-term back order and it will not be manufactured until capacity permits.
- Teva has mesna injection on back order and the company cannot estimate a release date.
Related Shortages
Updated
April 9, 2013; March 13, 2013; February 14, 2013; December 12, 2012; October 11, 2012; September 6, 2012; July 10, 2012; May 9, 2012; April 10, 2012; April 9, 2012; April 4, 2012; March 20, 2012; February 29, 2012; January 18, 2012; December 15, 2011; December 1, 2011; November 11, 2011; November 1, 2011; October 26, 2011; October 19, 2011; October 4, 2011; September 1, 2011; August 26, 2011; July 27, 2011; July 22, 2011; June 23, 2011; June 16, 2011; June 9, 2011; April 13, 2011; March 24, 2011; February 25, 2011; January 6, 2011; December 2, 2010; November 22, 2010; November 8, 2010; September 15, 2010; September 14, 2010; August 4, 2010; July 20, 2010; June 11, 2010; May 28, 2010, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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