[14 June 2013]
Products Affected - Description
Polymyxin B Powder for Solution, Bedford
500,000 units per vial, 10 count (NDC 55390-0139-10)
Polymyxin B Powder for Solution, Sagent
500,000 units per vial, 10 count (NDC 25021-0117-10)
Reason for the Shortage
- APP could not provide a reason for the shortage.
- Bedford has polymyxin B sulfate injection on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.
- Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
- Sagent suspended manufacturing of Polymyxin B sulfate injection in October, 2012.
Available Products
Polymyxin B Powder for Solution, APP
500,000 units per vial, 10 count (NDC 63323-0321-10)
Polymyxin B Powder for Solution, X-Gen
500,000 units per vial, single count (NDC 39822-0166-05)
500,000 units per vial, single count Novaplus vials (NDC 39822-0166-07)
Estimated Resupply Dates
- Bedford has polymyxin B injection on long-term back order. Product will not be manufactured until capacity permits.
- Sagent suspended manufacturing of polymyxin B injection in October, 2012.
Related Shortages
Updated
June 14, 2013; May 8, 2013; March 20, 2013; January 25, 2013; November 28, 2012; November 15, 2012, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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