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11/3/2024

Sterile Water for Injection - Small Volume Vials

Products Affected - Description

    • 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, Hikma, 10 mL small-volume vial, 10 count, NDC 00641-6147-10
    • 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, 20 mL small-volume vial, 25 count, NDC 00409-4887-20
    • Sterile Water for Injection injection, Pfizer, 50 mL small-volume vial, 25 count, NDC 00409-4887-50

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, 100 mL small-volume vial, 25 count, NDC 65219-0187-10
    • Sterile Water for Injection injection, Fresenius Kabi, 5 mL small-volume vial, 25 count, NDC 63323-0185-05
    • Sterile Water for Injection injection, Fresenius Kabi, 50 mL small-volume vial, 25 count, NDC 63323-0185-50
    • 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

Estimated Resupply Dates

    • Fresenius Kabi has sterile water for injection 10 mL and 20 mL vials on back order and the company estimates a release date of mid- to late-November 2024.
    • Hikma has sterile water for injection 10 mL vials on allocation.
    • Pfizer has sterile water for injection 10 mL, 20 mL, 50 mL, and 100 mL vials available in limited supply.

Implications for Patient Care

Updated

Updated November 3, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 6, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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