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8/6/2020

Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection

Products Affected - Description

    • 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, Akorn, 100 mcg/mL, 2 mL single dose vial, 10 count, NDC 17478-0055-02 - discontinued
    • 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, 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 - 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, 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 did not provide a reason for the shortage.
    • Akorn is no longer manufacturing dexmedetomidine vials.
    • Athenex has dexmedetomidine vials available.
    • AuroMedics did not provide a reason for the shortage.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.
    • Mylan did not provide a reason for the shortage.
    • Par has dexmedetomidine vials on shortage due to increased demand.
    • Pfizer has dexmedetomidine vials available.
    • Sandoz discontinued dexmedetomidine vials in April 2020.
    • Sun Pharma is no longer manufacturing dexmedetomidine.
    • Teva discontinued dexmedetomidine vials in July 2019.
    • WG Critical Care has dexmedetomidine vials available.

Available Products

    • 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, Fresenius Kabi, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 63323-0421-02
    • Dexmedetomidine hydrochloride solution for injection, Mylan, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 67457-0251-02

Estimated Resupply Dates

    • Accord has dexmedetomidine 100 mcg/mL 2 mL vials on allocation.
    • AuroMedics has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the company is releasing product as it becomes available.
    • Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates a release date of mid-August 2020.
    • Par has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the company is releasing product as it becomes available.
    • WG Critical Care has dexmedetomidine 100 mcg/mL 2 mL vials on allocation.
    • Pfizer has Precedex 100 mcg/mL 2 mL vials available in limited supply.

Updated

Updated August 6, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 8, 2018 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. © 2020, 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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