[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.
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.
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.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
« Back to Drug Shortage Product Bulletins