[15 January 2014]
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
- Fresenius Kabi (formerly APP) could not provide a reason for the shortage.
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.1
- Sagent suspended manufacturing of Polymyxin B sulfate injection in October, 2012.
Polymyxin B Powder for Solution, Fresenius Kabi (formerly 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 and the company cannot estimate a release date. Ben Venue manufactured polymyxin B injection for Bedford.
January 15, 2014; October 9, 2013; September 12, 2013; August 27, 2013; August 22, 2013; August 15, 2013; May 8, 2013; March 20, 2013; January 25, 2013; November 28, 2012; November 15, 2012, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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