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Amiodarone Injection

Last Updated: March 8, 2019
Status: Current

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, 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
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, Hikma, 50 mg/mL, 3 mL vial, 25 count, NDC 00143-9875-25
    • Amiodarone injection, Mylan Institutional, 50 mg/mL, 18 mL vial, 10 count, NDC 67457-0153-18

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 vials on back order and the company estimates a release date of mid-March 2019. There are short-dated 4 mL vials available with an expiration date of <3 months.
    • Mylan Institutional has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of mid-March 2019. The 9 mL vials are on back order and the company cannot estimate a release date.
    • Sagent has amiodarone 50 mg/mL 3 mL vials available with a short expiry of February 2019.

Updated

Updated March 8, 2019 by Megan Dryer, PharmD. Created January 6, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

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