Amiodarone Injection Shortage
Last Updated: April 21, 2025
Status: Current
Products Affected - Description
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- 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
- Amiodarone injection, Slate Run Pharmaceuticals, 50 mg/mL, 18 mL vial, 1 count, NDC 70436-0232-50
- Amiodarone injection, Slate Run Pharmaceuticals, 50 mg/mL, 3 mL vial, 10 count, NDC 70436-0232-52
- Amiodarone injection, Slate Run Pharmaceuticals, 50 mg/mL, 9 mL vial, 10 count, NDC 70436-0232-62
Reason for the Shortage
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- AuroMedics discontinued amiodarone in mid-2021.
- Baxter has Nexterone premixed bags on shortage due to manufacturing delays.
- Fresenius Kabi did not provide a reason for the shortage.
- Hikma did not provide a reason for the shortage.
- Viatris did not provide a reason for the shortage.
- Sagent discontinued amiodarone 50 mg/mL 3 mL syringes in June 2019.
- Slate Run Pharmaceuticals are launching amiodarone 3 mL, 9 mL, and 18 mL vials in March 2025.
Available Products
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- Nexterone injection, Baxter, 150 mg/100 mL, premixed bag, 12 count, NDC 43066-0150-10
- Amiodarone injection, Mylan Institutional (Viatris), 50 mg/mL, 18 mL vial, 10 count, NDC 67457-0153-18
- Amiodarone injection, Mylan Institutional (Viatris), 50 mg/mL, 3 mL vial, 10 count, NDC 67457-0153-03
- Amiodarone injection, Mylan Institutional (Viatris), 50 mg/mL, 9 mL vial, 10 count, NDC 67457-0153-09
Estimated Resupply Dates
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- Fresenius Kabi has amiodarone 50 mg/mL 3 mL and 9 mL vials on back order and the company cannot estimate a release date.
- Hikma has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of late-June 2025.
- Baxter has Nexterone 360 mg/200 mL premixes on allocation.
- Slate Run Pharmaceuticals has amiodarone 3 mL and 9 mL vials on back order and the company estimates a release date of early-June 2025. The 18 mL vials are on allocation.
Updated
Updated April 21, 2025 by Michelle Wheeler, PharmD, Drug Information Specialist. Created January 6, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.
Further information
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