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Ampicillin Sulbactam

[17 November 2014]

Products Affected - Description

Ampicillin Sulbactam powder for injection, AuroMedics Pharma
1.5 gram vial, 10 count (NDC 55150-0116-20)
3 gram vial, 10 count (NDC 55150-0117-20)
 
Ampicillin Sulbactam powder for injection, Hospira
1.5 gram vial, 10 count (NDC 00409-2988-01)
1.5 gram ADD-Vantage vial, 10 count (NDC 00409-2689-01)
3 gram vial, 10 count (NDC 00409-2998-03)
3 gram ADD-Vantage vial, 10 count (NDC 00409-2987-03)
15 gram bulk vial, 1 count (NDC 00409-2687-15)
 
Unasyn powder for injection, Pfizer
15 gram bulk vial, 1 count (NDC 00049-0024-28)
 
Ampicillin Sulbactam powder for injection, Sandoz
1.5 gram vial, 10 count (NDC 00781-3032-95)
3 gram vial, 10 count (NDC 00781-3033-95)
15 gram bulk vial, 1 count (NDC 00781-3034-46)
 
Ampicillin Sulbactam powder for injection, West-Ward
3 gram vial, 10 count (NDC 00641-6117-10)
 
Ampicillin Sulbactam powder for injection, WG Critical Care
1.5 gram vial, 10 count (NDC 44567-0210-10)
3 gram vial, 10 count (NDC 44567-0211-10)

Reason for the Shortage

  • AuroMedics Pharma launched new product in mid-June, 2012.
  • Hospira states that ampicillin sulbactam vials are on back order due to manufacturing delay.
  • Mylan Institutional discontinued ampicillin sulbactam injection in late 2013. 
  • Sagent has ampicillin sulbactam vials on allocation due to increased demand for the product.
  • WG Critical Care states the shortage is due to increased demand.
  • Pfizer and Sandoz cannot provide a reason for the shortage.
  • WG Critical Care launched ampicillin sulbactam 1.5 gram vials in March 2014.
  • West-Ward acquired several Baxter products in early 2011.

Available Products

Ampicillin Sulbactam powder for injection, Fresenius Kabi (formerly APP)
1.5 gram vial, 10 count (NDC 63323-0368-20)
3 gram vial, 10 count (NDC 63323-0369-20)
15 gram bulk vial, 1 count (NDC 63323-0370-62)
 
Ampicillin Sulbactam powder for injection, AuroMedics Pharma
15 gram bulk vial, 1 count (NDC 55150-0118-99)
 
Unasyn powder for injection, Pfizer
1.5 gram vial, 10 count (NDC 00049-0013-83)
3 gram vial, 10 count (NDC 00049-0014-83)
 
Ampicillin Sulbactam powder for injection, Sagent
1.5 gram vial, 10 count (NDC 25021-0142-20)
3 gram vial, 10 count (NDC 25021-0143-30)
15 gram bulk vial, 1 count (NDC 25021-0144-99)
 
Ampicillin Sulbactam powder for injection, West-Ward
1.5 gram vial, 10 count (NDC 00641-6116-10)
15 gram bulk vial, 1 count (NDC 00641-6118-01)
 
Ampicillin Sulbactam powder for injection, WG Critical Care
15 gram bulk vial, 1 count 9NDC 44567-0212-01)

Estimated Resupply Dates

  • AuroMedics has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company estimates a release date of late-November 2014 for the 3 gram vials and mid-December 2014 for the 1.5 gram vials.
  • Hospira has all ampicillin sulbactam presentations on back order and the company estimates a release date in 1st quarter 2015.
  • Pfizer has Unasyn 15 gram bulk vials on back order and the company estimates a release date in mid-November 2014.
  • Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.
  • West-Ward has ampicillin sulbactam 3 gram vials on back order and the company estimates a release date in mid-December to early-January 2014.
  • WG Critical Care has ampicillin sulbactam 1.5 gram vials on back order and the company cannot estimate a release date. Ampicillin sulbactam 3 gram vials are on back order and the company estimates a release date in late-January 2014.

Related Shortages

Updated

November 17, 2014; November 4, 2014; October 13, 2014; September 26, 2014; September 12, 2014; September 10, 2014; August 7, 2014; July 18, 2014; July 3, 2014; June 16, 2014; June 2, 2014; May 21, 2014; April 23, 2014; March 21, 2014; March 5, 2014; February 10, 2014; January 29, 2014; January 2, 2014; December 11, 2013; November 21, 2013; October 10, 2013; September 13, 2013; August 30, 2013; July 23, 2013; May 30, 2013; April 24, 2013; March 19, 2013; February 14, 2013; January 9, 2013; December 21, 2012; November 7, 2012; October 12, 2012; September 24, 2012; August 14, 2012; July 26, 2012; June 27, 2012; May 30, 2012; April 27, 2012; March 29, 2012; January 19, 2012; December 21, 2011; November 9, 2011; October 31, 2011; September 21, 2011; August 24, 2011; July 29, 2011; June 24, 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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