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11/5/2019

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, 1.5 gram, vial, 10 count, NDC 00641-6116-10
    • 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, 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, 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, Sagent, 3 gram, vial, 10 count, NDC 25021-0143-30
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Sandoz, 1.5 gram, vial, 10 count, NDC 00781-3032-95 - discontinued
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Sandoz, 15 gram, bulk vial, 1 count, NDC 00781-3034-46 - discontinued
    • Ampicillin Sodium and Sulbactam Sodium powder for solution for injection, Sandoz, 3 gram, vial, 10 count, NDC 00781-3033-95 - discontinued
    • 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

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 refuses to provide availability information
    • 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 and increased demand.
    • Sandoz discontinued ampicillin sulbactam.
    • WG Critical Care states the shortage is due to increased demand.

Available Products

    • 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, 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, 1.5 g, vial, NDC 66794-0206-02
    • 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, Piramal Critical Care, 3 g, vial, NDC 66794-0207-02

Estimated Resupply Dates

    • AuroMedics has ampicillin sulbactam 3 gram and 15 gram vials on intermittent back order and the company is releasing product as it becomes available. The 1.5 gram vials are on long-term back order and the company cannot estimate a release date.
    • Hikma has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company estimates a release date of mid-December 2019.
    • Pfizer has Unasyn 1.5 gram, 3 gram, and 15 gram bulk vials on back order and the company estimates a release date of December 2019. The 1.5 gram and 3 gram ADD-Vantage vials are on back order and the company estimates a release date of February 2020.
    • Sagent has ampicillin sulbactam 1.5 gram vials on allocation. The 3 gram, and 15 gram bulk vials are on back order and the company estimates a release date of November 2019 for the 3 gram vials and January 2020 for the 15 gram vials.
    • WG Critical Care has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram bulk vials on back order and the company estimates a release date of January 2020.

Updated

Updated November 5, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 24, 2011 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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