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7/9/2019

Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection

Products Affected - Description

    • Dexmedetomidine hydrochloride solution for injection, Akorn, 100 mcg/mL, 2 mL single dose vial, 10 count, NDC 17478-0055-02 - discontinued
    • Dexmedetomidine hydrochloride solution for injection, Athenex, 100 mcg/mL, 2 mL single dose vial, 10 count, NDC 70860-0605-02 - discontinued
    • Dexmedetomidine hydrochloride solution for injection, Sun Pharma, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 57664-0596-50 - discontinued
    • Dexmedetomidine hydrochloride solution for injection, Teva, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 45963-0906-42 - discontinued
    • Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 100 mcg/mL, 10 mL single dose vial, 4 count, NDC 44567-0601-04
    • Dexmedetomidine hydrochloride solution for injection, WG Critical Care, 100 mcg/mL, 4 mL single dose vial, 4 count, NDC 44567-0600-04

Reason for the Shortage

    • Accord has dexmedetomidine vials available.
    • Akorn is no longer manufacturing dexmedetomidine vials.
    • Athenex has dexmedetomidine vials available.
    • AuroMedics has dexmedetomidine vials available.
    • Fresenius Kabi has dexmedetomidine vials available.
    • Hikma has dexmedetomidine vials available.
    • Mylan refused to provide availability information.
    • Par has dexmedetomidine vials available.
    • Pfizer has dexmedetomidine vials available.
    • Sandoz has dexmedetomidine vials available.
    • Sun Pharma is no longer manufacturing dexmedetomidine.
    • Teva discontinued dexmedetomidine vials in July 2019.
    • WG Critical Care has dexmedetomidine vials on back order due to manufacturing delays.

Available Products

    • Precedex solution for injection, Pfizer, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 00409-1638-02
    • Dexmedetomidine hydrochloride solution for injection, Accord, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 16729-0239-93
    • Dexmedetomidine hydrochloride solution for injection, Athenex, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 70860-0605-03
    • Dexmedetomidine hydrochloride solution for injection, AuroMedics, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 55150-0209-02
    • Dexmedetomidine hydrochloride solution for injection, Fresenius Kabi, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 63323-0421-02
    • Dexmedetomidine hydrochloride solution for injection, Hikma, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 00143-9532-25
    • Dexmedetomidine hydrochloride solution for injection, Par Pharmaceuticals, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 42023-0146-25
    • Dexmedetomidine hydrochloride solution for injection, Sandoz, 100 mcg/mL, 2 mL single dose vial, 10 count, NDC 00781-3297-95

Estimated Resupply Dates

    • WG Critical Care has dexmedetomidine 100 mcg/mL 4 mL and 10 mL vials on intermittent back order and the company is releasing supplies as they become available.

Updated

Updated July 9, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created November 8, 2018 by Stephen Andrews, PharmD, BCPS, 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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