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11/22/2019

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, 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
    • Amiodarone injection, Sagent, 50 mg/mL, 3 mL syringe, 10 count, NDC 25021-0302-66 - discontinued

Reason for the Shortage

    • Baxter had Nexterone premixed bags on shortage due to manufacturing delays.
    • Mylan Institutional 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.
    • 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, 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

Estimated Resupply Dates

    • AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on back order and the company estimates a release date of December 2019.
    • Mylan Institutional has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on back order and the company estimates a release date of mid-to late-February 2020 for the 3 mL vials and mid-January 2020 for the 9 mL and 18 mL vials.

Updated

Updated November 22, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 6, 2018 by Michelle Wheeler, PharmD, 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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