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10/17/2024

Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection

Products Affected - Description

    • 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, 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

Reason for the Shortage

    • Accord has dexmedetomidine vials on shortage due to manufacturing issues.
    • Eugia has dexmedetomidine vials available.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.
    • Meitheal has dexmedetomidine vials available.
    • Pfizer has Precedex vials available.
    • Par has dexmedetomidine vials available.
    • Piramal Critical Care has dexmedetomidine vials available.
    • Viatris has dexmedetomidine vials available.
    • WG Critical Care has dexmedetomidine vials available.

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, Eugia US, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 55150-0209-02
    • Dexmedetomidine hydrochloride solution for injection, Meitheal Pharmaceuticals, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 71288-0505-03
    • Dexmedetomidine hydrochloride solution for injection, Mylan (Viatris), 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 67457-0251-02
    • 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, Piramal Critical Care, 100 mcg/mL, 2 mL single dose vial, 25 count, NDC 66794-0233-02
    • 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

Estimated Resupply Dates

    • Accord has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company cannot estimate a release date.
    • Fresenius Kabi has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates a release date of mid-November 2024.
    • Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company cannot estimate a release date.

Updated

Updated October 17, 2024 by Leslie Jensen, PharmD, Drug Information Specialist. Created July 3, 2024 by Leslie Jensen, 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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