[09 May 2013]
Products Affected - Description
Mannitol injection, American Regent
250 mg/mL, 50 mL vial, 25 count (NDC 00517-4050-25)
Mannitol injection, APP
250 mg/mL, 50 mL vial, 25 count (NDC 63323-0024-25)
Osmitrol injection, Baxter
50 mg/mL, 1000 mL premixed bag (NDC 00338-0351-04)
100 mg/mL, 500 mL premixed bag (NDC 00338-0353-03)
150 mg/mL, 500 mL premixed bag (NDC 00338-0355-03)
200 mg/mL, 250 mL premixed bag (NDC 00338-0357-02)
200 mg/mL, 500 mL premixed bag (NDC 00338-0357-03)
Mannitol injection, Hospira
250 mg/mL, 50 mL vial, 25 count (NDC 00409-4031-01)
Reason for the Shortage
- Hospira has mannitol injection on shortage due to manufacturing delays.
- APP has mannitol injection on shortage due to increased demand for the product.
- American Regent had temporarily suspended manufacture of most drug products in April, 2011.
- American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
- Baxter could not provide a reason for the shortage.
Mannitol injection, BBraun
200 mg/mL, 250 mL premixed bag (NDC 00264-7578-20)
200 mg/mL, 500 mL premixed bag (NDC 00264-7578-10)
Mannitol injection, Hospira
200 mg/mL, 250 mL premixed bag (NDC 00409-7715-02)
200 mg/mL, 500 mL premixed bag (NDC 00409-7715-03)
Estimated Resupply Dates
- American Regent has mannitol 250 mg/mL 50 mL vials on back order and the company cannot estimate a release date.
- APP has mannitol 250 mg/mL 50 mL vials on back order with an estimated release date in late-May 2013.
- Baxter has mannitol 50 mg/mL, 100 mg/mL, and 150 mg/mL presentations on back order and the company cannot estimate a release date. Baxter has a limited supply available of mannitol 200 mg/mL 250 mL and 500 mL presentations.
- Hospira has mannitol 250 mg/mL 50 mL vials on intermittent back order and the company is releasing product as it becomes available.
May 9, 2013; April 3, 2013; March 28, 2013; March 5, 2013; February 6, 2013; January 16, 2013; December 31, 2012; December 17, 2012; November 28, 2012; November 20, 2012; October 10, 2012; August 17, 2012; July 5, 2012; May 18, 2012; May 7, 2012; April 26, 2012; April 12, 2012; March 21, 2012; February 24, 2012; February 8, 2012, January 25, 2012; December 28, 2011; December 14, 2011; November 16, 2011; November 15, 2011, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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