[15 May 2013]
Products Affected - Description
Fluconazole Injection, 2 mg/mL, Bedford
100 mL vials (NDC 55390-0012-01)
200 mL vials (NDC 55390-0046-01)
200 mL premixed bag (NDC 55390-0228-01)
Fluconazole Injection, 2 mg/mL, Teva
100 mL vial (NDC 00703-1019-09)
100 mL premixed bag (NDC 00703-1029-30)
200 mL vial (NDC 00703-1010-09)
200 mL premixed bag (NDC 00703-1020-30)
Reason for the Shortage
- Teva has fluconazole injection on shortage due to manufacturing delays.
- Bedford has fluconazole 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.
- Pfizer discontinued their last available fluconazole premixed bags in May, 2011.
- Sagent had fluconazole injection on shortage due to manufacturing delays.
Available Products
Fluconazole Injection 2 mg/mL, Baxter
100 mL premixed bag in NaCl (NDC 00338-6046-48)
200 mL premixed bag in NaCl (NDC 00338-6045-37)
Fluconazole Injection, 2 mg/mL, Bedford
50 mL vials (NDC 55390-0194-01)
100 mL premixed bag (NDC 55390-0227-01)
Fluconazole Injection, 2 mg/mL, Hospira
100 mL premixed bag in dextrose (NDC 00409-4684-23)
200 mL premixed bag in dextrose (NDC 00409-468402)
100 mL premixed bag in NaCl (NDC 00409-4688-23)
200 mL premixed bag in NaCl (NDC 00409-4688-02)
100 mL Novaplus premixed bag in NaCl (NDC 00409-4688-28)
200 mL Novaplus premixed bag in NaCl (NDC 00409-4688-34)
Fluconazole Injection, 2 mg/mL, Sagent
100 mL premixed bag in NaCl (NDC 25021-0113-82)
200 mL premixed bag in NaCl (NDC 25021-0113-87)
Fluconazole Injection, 2 mg/mL, West-Ward
100 mL vial, in NaCl (NDC 00143-9899-91)
100 mL premixed bag in NaCl (NDC 00143-9669-06)
200 mL premixed bag in NaCl (NDC 00143-9668-06)
100 mL premixed bag in Dextrose (NDC 00143-9667-06)
200 mL premixed bag in Dextrose (NDC 00143-9666-06)
Estimated Resupply Dates
- Bedford has fluconazole 2 mg/mL 100 mL vials, 200 mL vials, and 200 mL premixed bags on long-term back order and the company cannot estimate a release date. Production will begin once capacity permits.
- Teva has all fluconazole 2 mg/mL injection presentations on long term back order and the company cannot estimate a release date.
Related Shortages
Updated
May 15, 2013; May 8, 2013; April 17, 2013; April 10, 2013; March 6, 2013; December 18, 2012; December 3, 2012; August 30, 2012; July 13, 2012; June 25, 2012; May 9, 2012; April 10, 2012; March 29, 2012; March 15, 2012; March 2, 2012; January 31, 2012; December 28, 2011; December 7, 2011; November 3, 2011; October 20, 2011; October 14, 2011; September 20, 2011; August 25, 2011; August 4, 2011; July 8, 2011; June 23, 2011; May 20, 2011; March 29, 2011; March 18, 2011; March 3, 2011; January 20, 2011; December 3, 2010; October 11, 2010; September 3, 2010; August 11, 2010; June 1, 2010, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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