[17 May 2013]
Products Affected - Description
Tobramycin Solution for Injection, APP
10 mg/mL, 2 mL vial (NDC 63323-0305-02)
40 mg/mL, 2 mL vial (NDC 63323-0306-02)
40 mg/mL, 30 mL vial (NDC 63323-0306-30)
40 mg/mL, 50 mL vial (NDC 63323-0307-51)
Tobramycin Solution for Injection, Hospira
10 mg/mL, 2 mL vial (NDC 00409-3577-01)
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, Teva
40 mg/mL, 2 mL vial (NDC 00703-9402-04)
40 mg/mL, 30 mL vial (NDC 00703-9416-01)
Tobramycin Solution for Injection, Pfizer
40 mg/mL, 2 mL vial (NDC 00069-0088-02)
40 mg/mL, 30 mL vial (NDC 00069-0091-03)
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.
- APP has tobramycin solution for injection on shortage due to increased demand.
- Pfizer acquired tobramycin injection from Akorn in early-May, 2011.
- Pfizer states the reason for the shortage is manufacturing delays.
Available Products
Tobramycin Lyophilized Powder for Injection, APP
1.2 gram 50 mL vial, preservative-free, 6 count (NDC 63323-0303-51)
1.2 gram 50 mL Novaplus vial, preservative-free, 6 count (NDC 63323-0303-55)
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)
Tobramycin Solution for Injection, Pfizer
40 mg/mL, 30 mL Novaplus vial, 10 count (NDC 00069-0302-02)
Estimated Resupply Dates
- APP has tobramycin 10 mg/mL 2mL, 40 mg/mL 2 mL, and 40 mg/mL 30 mL vials on back order and the company estimates a release date in late-May 2013. Tobramycin 40 mg/mL 50 mL vials are on back order with an estimated release date in early-June 2013.
- Hospira has tobramycin 10 mg/mL 2 mL vials, 40 mg/mL 2 mL vials, and 40 mg/mL 50 mL vials on back order with an estimated release date of 3rd quarter 2013. Tobramycin 80 mg/mL 100 mL premixed bags are on back order and the company estimates a release date in June 2013.
Teva has tobramycin 40 mg/mL solution for injection on long term back order and the company cannot estimate a release date.
- Pfizer has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order with an estimated release date of late-June 2013.
Related Shortages
Updated
May 17, 2013; May 3, 2013; April 29, 2013; April 4, 2013; March 20, 2013; March 6, 2013; February 25, 2013; February 6, 2013; January 16, 2013; January 2, 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 18, 2012; January 6, 2012; December 21, 2011; December 8, 2011; December 1, 2011; November 28, 2011; November 2, 2011; October 26, 2011; September 29, 2011; September 28, 2011; September 19, 2011; September 7, 2011; September 1, 2011; August 26, 2011; August 9, 2011; July 28, 2011; July 14, 2011; June 24, 2011; June 8, 2011; May 17, 2011; May 10, 2011; May 6, 2011; April 20, 2011; March 10, 2011; February 17, 2011; December 21, 2010; December 6, 2010, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
Disclaimer
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