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Ampicillin Sulbactam

[03 September 2015]

Products Affected - Description

Ampicillin Sulbactam powder for solution for injection, AuroMedics
1.5 gram, vial, 10 count (NDC 55150-0116-20)
3 gram, vial, 10 count (NDC 55150-0117-20)
15 gram, bulk vial, 1 count (NDC 55150-0118-99)
Ampicillin Sulbactam powder for solution for injection, Fresenius Kabi
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 solution 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)
 
Ampicillin Sulbactam powder for solution 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 solution 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 solution for injection, WG Critical Care
1.5 gram, vial, 10 count (NDC 44567-0210-10)
3 gram, vial, 10 count (NDC 44567-0211-10)
15 gram, bulk vial, 1 count (NDC 44567-0212-01)
 
Ampicillin Sulbactam powder for solution for injection, West-Ward
1.5 gram, vial, 10 count (NDC 00641-6116-10)
3 gram, vial, 10 count (NDC 00641-6117-10)
15 gram, bulk vial, 1 count (NDC 00641-6118-01)
 
Unasyn powder for solution for injection, Pfizer
1.5 gram, vial, 10 count (NDC 00049-0013-83)
3 gram, vial, 10 count (NDC 00049-0014-83)
15 gram, bulk vial, 1 count (NDC 00049-0024-28)

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

There are insufficient supplies for usual ordering.

Estimated Resupply Dates

  • AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on intermittent back order and the company is releasing product as it becomes available.
  • Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company estimates a release date of 3rd quarter 2015 for the 15 gram vials and 4th quarter 2015 for the 1.5 gram and 3 gram vials.
  • Hospira has all ampicillin sulbactam presentations on back order and the company estimates a release date of 1st quarter 2016.
  • Pfizer has Unasyn 1.5 gram vials on intermittent back order and the company is releasing product as it becomes available. The 3 gram vials are on back order and the company estimates a release date of late-September 2015. The 15 gram bulk vials are on back order and the company estimates a release date in late-October 2015.
  • Sagent has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company estimates a release date of early-September 2015 for the 3 gram and 15 gram vials and September for the 1.5 gram vials.
  • Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials temporarily unavailable and the company cannot estimate a release date.
  • West-Ward has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on allocation.
  • WG Critical Care has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company cannot estimate a release date for the 3 gram and 15 gram vials. The company estimates a release date of late-September 2015 for the 3 gram vials.

Related Shortages

Updated

September 3, July 20, 14 and 5, June 15 and 5, May 22, April 30 and 16, March 20, 12, 5 and 3, February 18 and 4, January 20 and 9, 2015; December 11, November 17 and 4, October 13, September 26, 12 and 10, August 7, July 18 and 3, June 16 and 2, May 21 and 5, April 23, March 31, 21, 10 and 5, February 10, January 29 and 2, 2014; December 11, November 21, October 10, September 13, August 30, 19, 13 and 6, July 23, 12 and 3, May 30, April 24 and 8, March 19 and 4, February 14 and 1, January 9, 2013; December 21, 13 and 7, October 12, September 24 and 6, August 30, 29 and 14, July 26 and 6, June 27 and 14, May 30 and 7, April 27, 13 and 6, March 29, January 19, 2012; December 21 and 15, November 9, October 31 and 28, September 30 and 21, August 31, 24, 17 and 11, July 29, June 24, 2011, University of Utah, Drug Information Service. Copyright 2015, 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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