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2/2/2021

Amiodarone Injection

Products Affected - Description

    • Amiodarone injection, AuroMedics, 50 mg/mL, 18 mL vial, 1 count, NDC 55150-0182-18
    • Amiodarone injection, AuroMedics, 50 mg/mL, 3 mL vial, 10 count, NDC 55150-0180-03
    • Amiodarone injection, AuroMedics, 50 mg/mL, 9 mL vial, 10 count, NDC 55150-0181-09
    • Amiodarone injection, Fresenius Kabi, 50 mg/mL, 3 mL vial, 10 count, NDC 63323-0616-03
    • Amiodarone injection, Fresenius Kabi, 50 mg/mL, 9 mL vial, 10 count, NDC 63323-0616-09
    • Amiodarone injection, Hikma, 50 mg/mL, 3 mL vial, 25 count, NDC 00143-9875-25
    • Amiodarone injection, Sagent, 50 mg/mL, 3 mL syringe, 10 count, NDC 25021-0302-66 - discontinued

Reason for the Shortage

    • Baxter has Nexterone premixed bags available.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count presentation was discontinued in December 2018.
    • Mylan Institutional did not provide a reason for the shortage.
    • Sagent discontinued amiodarone 50 mg/mL 3 mL syringes in June 2019.

Available Products

    • Nexterone injection, Baxter, 150 mg/100 mL, premixed bag, 12 count, NDC 43066-0150-10
    • Nexterone injection, Baxter, 360 mg/200 mL, premixed bag, 10 count, NDC 43066-0360-20
    • Amiodarone injection, Mylan Institutional, 50 mg/mL, 18 mL vial, 10 count, NDC 67457-0153-18
    • Amiodarone injection, Mylan Institutional, 50 mg/mL, 3 mL vial, 10 count, NDC 67457-0153-03
    • Amiodarone injection, Mylan Institutional, 50 mg/mL, 9 mL vial, 10 count, NDC 67457-0153-09

Estimated Resupply Dates

    • AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on long-term back order and the company cannot estimate a release date.
    • Fresenius Kabi has amiodarone 50 mg/mL 9 mL vials on back order and the company estimates a release date of early- to mid-March 2021. There are short-dated 3 mL vials available with an expiration date of < 8 months.
    • Hikma has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of early- to mid-February 2021.

Updated

Updated February 2, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 6, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2021, 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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