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3/20/2023

Fentanyl Citrate Injection

Products Affected - Description

    • Fentanyl citrate solution for injection, Akorn, 50 mcg/mL, 2 mL ampule, 10 count, NDC 17478-0030-02 - discontinued
    • Fentanyl citrate solution for injection, Akorn, 50 mcg/mL, 5 mL ampule, 10 count, NDC 17478-0030-05 - discontinued
    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 2 mL vial, 25 count, NDC 63323-0806-02
    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 20 mL vial, 25 count, NDC 63323-0806-20
    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 50 mL vial, 1 count, NDC 63323-0806-50
    • Fentanyl citrate solution for injection, Hikma, 50 mcg/mL, 1 mL vial, 25 count, NDC 00641-6247-25
    • Fentanyl citrate solution for injection, Hikma, 50 mcg/mL, 2 mL vial, 25 count, NDC 00641-6027-25
    • Fentanyl citrate solution for injection, Hikma, 50 mcg/mL, 5 mL vial, 25 count, NDC 00641-6028-25
    • Fentanyl citrate solution for injection, Hikma, 50 mcg/mL, 50 mL vial, 1 count, NDC 00641-6030-01
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 10 mL vial, 25 count, NDC 00409-9094-28
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 2 mL Carpuject syringe, 10 count, NDC 00409-1276-32 - discontinued
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 2 mL ampule, 10 count, NDC 00409-9093-32
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 2 mL vial, 25 count, NDC 00409-9094-22
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 20 mL vial, 25 count, NDC 00409-9094-31
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 5 mL ampule, 10 count, NDC 00409-9093-35
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 5 mL vial, 25 count, NDC 00409-9094-25
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 50 mL vial, 25 count, NDC 00409-9094-61

Reason for the Shortage

    • Akorn ceased operations in February 2023.
    • Fresenius Kabi had fentanyl on shortage due to increased demand.
    • Hikma had fentanyl injection on shortage due to supply and demand issues. They are not currently marketing fentanyl ampules, just vials.
    • Pfizer has fentanyl injection on shortage due to manufacturing delays.

Available Products

    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 1 mL syringe, 10 count, NDC 63323-0808-11
    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 1 mL vial, 25 count, NDC 63323-0806-01
    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 5 mL vial, 25 count, NDC 63323-0806-05
    • Fentanyl citrate solution for injection, Hikma, 50 mcg/mL, 20 mL vial, 1 count, NDC 00641-6029-01

Estimated Resupply Dates

    • Fresenius Kabi has fentanyl 50 mcg/mL 2 mL, 20 mL, and 50 mL vials on back order and the company estimates a release date of late-March 2023.
    • Hikma has fentanyl 50 mcg/mL 1 mL vials on back order and the company estimates a release date of late-March 2023. The 2 mL, 5 mL, and 50 mL vials are on allocation.
    • Pfizer has fentanyl 50 mcg/mL 2 mL and 5 mL ampules on back order and the company estimates a release date of January 2024 for the 2 mL ampules and July 2023 for the 5 mL ampules. The 5 mL and 10 mL vials are on back order and the company estimates a release date of March 2023. The 2 mL vials, 20 mL vials, and 50 mL vials are available in limited supply.

Implications for Patient Care

Updated

Updated March 20, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 8, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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