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11/15/2022

Sterile Water for Injection - Small Volume Vials

Products Affected - Description

    • 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, 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, Medefil, Inc., 10 mL syringe, 60 count, NDC 64253-0020-30
    • 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

Reason for the Shortage

    • American Regent discontinued sterile water for injection in early-2021.
    • Fresenius Kabi had sterile water on shortage due to increased demand.
    • Hikma did not provide a reason for the shortage.
    • Medefil has sterile water for injection in syringes on shortage due to increased demand.
    • Pfizer has sterile water for injection in vials on shortage due to increased demand.

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, 5 mL small-volume vial, 25 count, NDC 63323-0185-05
    • Sterile Water for Injection injection, Pfizer, 10 mL small-volume vial, 25 count, NDC 00409-4887-10
    • Sterile Water for Injection injection, Pfizer, 20 mL small-volume vial, 25 count, NDC 00409-4887-20

Estimated Resupply Dates

    • Fresenius Kabi has sterile water for injection 20 mL and 50 mL vials on back order and the company cannot estimate a release date.
    • Hikma has sterile water for injection 10 mL vials on allocation.
    • Medefil has sterile water for injection 10 mL syringes on intermittent back order and the company is releasing product as it becomes available.
    • Pfizer has sterile water for injection 50 mL vials available in limited supply. The 100 mL vials are on back order and the company estimates a release date of January 2023.

Implications for Patient Care

Updated

Updated November 15, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 6, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2022, 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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