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Tobramycin Injection

[24 October 2014]

Products Affected - Description

Tobramycin Solution for Injection, Fresenius Kabi
10 mg/mL, 2 mL vial (NDC 63323-0305-02)
40 mg/mL, 2 mL vial (NDC 63323-0306-02)
 
Tobramycin Solution for Injection, Hospira
40 mg/mL, 2 mL vial (NDC 00409-3578-01)
40 mg/mL, 50 mL vial (NDC 00409-3590-02)
80 mg/100 mL premixed bags (NDC 00409-3470-23)
 
Tobramycin Solution for Injection, Mylan Institutional
40 mg/mL, 30 mL vial (NDC 67457-0428-30)
 
Tobramycin Solution for Injection, Teva
40 mg/mL, 2 mL vial (NDC 00703-9402-04)
40 mg/mL, 30 mL vial (NDC 00703-9416-01)

Reason for the Shortage

  • Teva has tobramycin solution for injection on shortage due to manufacturing delays.
  • Hospira has tobramycin on shortage due to manufacturing delays.
  • Fresenius Kabi has tobramycin solution for injection on shortage due to increased demand.
  • Pfizer acquired tobramycin injection from Akorn in early-May, 2011.
  • Pfizer divested tobramycin injection to Mylan Institutional on December 6, 2013.
  • Mylan Institutional could not provide a reason for the shortage.

Available Products

Tobramycin Solution for Injection, Fresenius Kabi
40 mg/mL, 30 mL vial (NDC 63323-0306-30)
40 mg/mL, 50 mL vial (NDC 63323-0307-51)
 
Tobramycin Lyophilized Powder for Injection, Fresenius Kabi
1.2 gram 50 mL vial, preservative-free, 6 count (NDC 63323-0303-51)

Tobramycin Solution for Injection, Hospira
10 mg/mL, 2 mL vial (NDC 00409-3577-01)
 
Tobramycin Solution for Injection, Mylan Institutional
40 mg/mL, 2 mL vial (NDC 00069-0088-02)
 
Tobramycin Lyophilized Powder for Injection, X-Gen
1.2 gram 50 mL vial, preservative-free, 1 count (NDC 39822-0412-01)
1.2 gram 50 mL vial, preservative-free, 6 count (NDC 39822-0412-06)

Estimated Resupply Dates

  • Fresenius Kabi has tobramycin 40 mg/mL 2 mL vials on intermittent back order and the company is releasing product as it becomes available. Tobramycin 10 mg/mL 2 mL vials are available with short expiration dating (< 8 and 9 months).
  • Hospira has tobramycin 40 mg/mL 2 mL and 50 mL vials and 80 mg/mL 100 mL premixed bags on back order and the company cannot estimate a release date.
  • Mylan Institutional has tobramycin 40 mg/mL 30 mL vials on back order and the company estimates a release date of mid-November 2014.
  • Teva has tobramycin 40 mg/mL solution for injection on long term back order and the company estimates a release date in the first quarter of 2015.

Related Shortages

Updated

October 24, 2014; October 9, 2014; October 3, 2014; September 24, 2014; September 8, 2014; August 28, 2014; July 31, 2014; June 12, 2014; April 11, 2014; February 27, 2014; January 24, 2014; December 10, 2013; November 19, 2013; October 24, 2013; August 27, 2013; July 30, 2013; July 22, 2013; June 19, 2013; May 17, 2013; April 29, 2013; March 20, 2013; March 6, 2013; February 6, 2013; January 16, 2013; December 3, 2012; November 14, 2012; September 17, 2012; August 2, 2012; July 6, 2012; June 6, 2012; April 17, 2012; March 21, 2012; February 29, 2012; February 10, 2012; February 8, 2012; January 25, 2012; January 6, 2012; December 21, 2011; November 28, 2011; November 2, 2011; October 26, 2011; September 29, 2011; September 1, 2011; August 26, 2011; August 9, 2011; July 28, 2011; July 14, 2011; University of Utah, Drug Information Service. Copyright 2014, 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.

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