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5/3/2019

Amiodarone Injection

Products Affected - Description

    • 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, 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, 10 count, NDC 00143-9875-10 - discontinued
    • 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

Reason for the Shortage

    • Baxter has 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.

Available Products

    • 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 intermittent back order and the company is releasing product as it becomes available.
    • Baxter has Nexterone 150 mg/100mL and 360 mg/200mL premixed bags on allocation.
    • Fresenius Kabi has amiodarone 50 mg/mL 3 mL and 9 mL vials on back order and the company estimates a release date of late-May 2019.
    • Hikma has amiodarone 50 mg/mL 3 mL vials on allocation.
    • Sagent has amiodarone 50 mg/mL 3 mL vials on back order and the company cannot estimate a release date.

Updated

Updated May 3, 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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