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11/12/2021

Ampicillin Sodium and Sulbactam Sodium Injection

Products Affected - Description

    • Unasyn powder for solution for injection, Pfizer, 1.5 gram, vial, 10 count, NDC 00049-0013-83
    • Unasyn powder for solution for injection, Pfizer, 15 gram, bulk vial, 1 count, NDC 00049-0024-28
    • Unasyn powder for solution for injection, Pfizer, 3 gram, vial, 10 count, NDC 00049-0014-83
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, AuroMedics, 1.5 gram, vial, 10 count, NDC 55150-0116-20
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, AuroMedics, 15 gram, bulk vial, 1 count, NDC 55150-0118-99
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, AuroMedics, 3 gram, vial, 10 count, NDC 55150-0117-20
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Hikma, 15 gram, bulk vial, 1 count, NDC 00641-6118-01
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Hikma, 3 gram, vial, 10 count, NDC 00641-6117-10
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Mylan Institutional, 1.5 gram, vial, 10 count, NDC 67457-0348-10
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Sagent, 3 gram, vial, 10 count, NDC 25021-0143-30

Reason for the Shortage

    • AuroMedics has ampicillin sulbactam vials on back order due to increased demand and manufacturing delays.
    • Fresenius Kabi is not currently marketing ampicillin sulbactam injection.
    • Meitheal Pharmaceuticals has ampicillin sulbactam available.
    • Mylan Institutional did not provide a reason for the shortage.
    • Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-Vantage vials.
    • Piramal Critical Care has ampicillin sulbactam available.
    • Sagent has ampicillin sulbactam vials on back order due to manufacturing delays.
    • Sandoz discontinued ampicillin sulbactam.
    • WG Critical Care states the shortage was due to increased demand.

Available Products

    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Hikma, 1.5 gram, vial, 10 count, NDC 00641-6116-10
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Meitheal Pharmaceuticals, 1.5 gram, vial, 10 count, NDC 71288-0005-20
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Meitheal Pharmaceuticals, 15 gram, vial, 1 count, NDC 71288-0007-25
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Meitheal Pharmaceuticals, 3 gram, vial, 10 count, NDC 71288-0006-30
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Mylan Institutional, 15 gram, bulk vial, 1 count, NDC 67457-0649-10
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Mylan Institutional, 3 gram, vial, 10 count, NDC 67457-0349-10
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Pfizer, 1.5 gram, ADD-Vantage vial, 10 count, NDC 00409-2689-01
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Pfizer, 3 gram, ADD-Vantage vial, 10 count, NDC 00409-2987-03
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Piramal Critical Care, 1.5 g, vial, 10 count, NDC 66794-0206-41
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Piramal Critical Care, 15 g, vial, NDC 66794-0208-15
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Piramal Critical Care, 3 g, vial, 10 count, NDC 66794-0207-41
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Sagent, 1.5 gram, vial, 10 count, NDC 25021-0142-20
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Sagent, 15 gram, bulk vial, 1 count, NDC 25021-0144-99
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, WG Critical Care, 1.5 gram, vial, 10 count, NDC 44567-0210-10
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, WG Critical Care, 15 gram, bulk vial, 1 count, NDC 44567-0212-01
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, WG Critical Care, 3 gram, vial, 10 count, NDC 44567-0211-10

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.
    • Hikma has ampicillin sulbactam 3 gram vials on back order and the company estimates a release date of 1st quarter 2022. The 15 gram vials are on back order and the company cannot estimate a release date.
    • Mylan Institutional has ampicillin sulbactam 1.5 gram vials on back order and the company estimates a release date of early-December 2021.
    • Pfizer has Unasyn 3 gram and 15 gram vials on back order and the company estimates a release date of November 2021 for the 3 gram vials and December 2021 for the 15 gram vials. The 1.5 gram vials are available in limited supply.
    • Sagent has ampicillin sulbactam 3 gram vials on limited allocation.

Updated

Updated November 12, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 24, 2011 by Leslie Jensen, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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