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Sterile Water for Injection - Small Volume Vials Shortage

Last Updated: March 10, 2025
Status: Current

Products Affected - Description
    • Sterile Water for Injection injection, Fresenius Kabi, 100 mL small-volume vial, 25 count, NDC 65219-0187-10
    • Sterile Water for Injection injection, Fresenius Kabi, 50 mL small-volume vial, 25 count, NDC 63323-0185-50
    • Sterile Water for Injection injection, Hikma, 10 mL small-volume vial, 10 count, NDC 00641-6147-10
    • Sterile Water for Injection injection, Pfizer, 20 mL small-volume vial, 25 count, NDC 00409-4887-20
Reason for the Shortage
    • American Regent discontinued sterile water for injection in early-2021.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.
    • Medefil has sterile water for injection in syringes available.
    • Pfizer had sterile water for injection in vials on shortage due to manufacturing delays.
Available Products
    • Sterile Water for Injection injection, Fresenius Kabi, 10 mL small-volume vial, 25 count, NDC 63323-0185-10
    • Sterile Water for Injection injection, Fresenius Kabi, 20 mL small-volume vial, 25 count, NDC 63323-0185-20
    • Sterile Water for Injection injection, Fresenius Kabi, 5 mL small-volume vial, 25 count, NDC 63323-0185-05
    • Sterile Water for Injection injection, Medefil, Inc., 10 mL syringe, 10 count, NDC 64253-0020-91
    • Sterile Water for Injection injection, Medefil, Inc., 10 mL syringe, 60 count, NDC 64253-0020-30
    • Sterile Water for Injection injection, Pfizer, 10 mL small-volume vial, 25 count, NDC 00409-4887-10
    • Sterile Water for Injection injection, Pfizer, 100 mL small-volume vial, 25 count, NDC 00409-4887-99
    • Sterile Water for Injection injection, Pfizer, 50 mL small-volume vial, 25 count, NDC 00409-4887-50

Estimated Resupply Dates

    • Fresenius Kabi has sterile water for injection 50 mL and 100 mL vials on back order and the company cannot estimate a release date.
    • Hikma has sterile water for injection 10 mL vials on allocation.
    • Pfizer has sterile water for injection 20 mL vials available in limited supply.

Implications for Patient Care

Updated

Updated March 10, 2025 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 6, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.