[20 May 2013]
Products Affected - Description
Bumetanide 0.25 mg/mL, Bedford
2 mL vial (NDC 55390-0500-02)
4 mL vial (NDC 55390-0500-05)
10 mL vial (NDC 55390-0500-10)
Bumetanide 0.25 mg/mL, Hospira
4 mL vial (NDC 00409-1412-04)
4 mL Novaplus vial (NDC 00409-1412-49)
10 mL vial (NDC 00409-1412-10)
Reason for the Shortage
- Bedford has bumetanide 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. Baxter discontinued bumetanide 0.25 mg/mL 2 mL vial in early-2011.
- Baxter discontinued bumetanide 0.25 mg/mL 2 mL vial in early-2011.
- West-Ward acquired several Baxter products including bumetanide in mid-2011. Bumetanide was on shortage because demand exceeded supply.
- Hospira has bumetanide on shortage due to manufacturing delays.
Available Products
Bumetanide 0.25 mg/mL, West-Ward
4 mL vial (NDC 00641-6008-10)
10 mL vial (NDC 00641-6007-10)
Bumetanide 0.25 mg/mL, Hospira
10 mL Novaplus vial (NDC 00409-1412-50)
Estimated Resupply Dates
- Bedford has bumetanide 4 mL and 10 mL vials on long-term back order. The company does not plan to resume production until capacity permits.
- Hospira has bumetanide 4 mL vials on back order and the company estimates a release date in May 2013. Bumetanide 4 mL Novaplus vials have an estimated release date of June 2013. Bumetanide 10 mL vials have an estimated release date in fourth quarter of 2013.
Related Shortages
Updated
May 20, 2013; May 6, 2013; April 24, 2013; March 29, 2013; March 7, 2013; February 15, 2013; January 28, 2013; January 23, 2013; January 15, 2013; December 19, 2012; November 27, 2012; November 1, 2012; October 15, 2012; October 3, 2012; September 17, 2012; September 5, 2012; August 7, 2012; July 12, 2012; July 10, 2012; May 24, 2012; April 18, 2012; April 4, 2012; March 21, 2012; March 12, 2012; February 21, 2012; February 3, 2012, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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