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5/12/2020

Fentanyl Citrate Injection

Products Affected - Description

    • Fentanyl citrate solution for injection, Akorn, 50 mcg/mL, 2 mL ampule, 10 count, NDC 17478-0030-02
    • 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, 5 mL vial, 25 count, NDC 63323-0806-05
    • 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, 2 mL vial, 25 count, NDC 00641-6027-25
    • Fentanyl citrate solution for injection, Hikma, 50 mcg/mL, 20 mL vial, 25 count, NDC 00641-6029-25
    • 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
    • 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 has fentanyl on shortage due to increased demand.
    • Fresenius Kabi on shortage due to increased demand.
    • Hikma has 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 increased demand. The 20 mL ampules were discontinued in September 2017.

Available Products

    • Fentanyl citrate solution for injection, Akorn, 50 mcg/mL, 5 mL ampule, 10 count, NDC 17478-0030-05
    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 1 mL vial, 25 count, NDC 63323-0806-01
    • Fentanyl citrate solution for injection, Pfizer, 50 mcg/mL, 2 mL ampule, 10 count, NDC 00409-9093-32

Estimated Resupply Dates

    • Akorn has fentanyl 50 mcg/mL 2 mL ampules on back order and the company estimates a release date of mid-June 2020.
    • Fresenius Kabi has fentanyl 50 mcg/mL 20 mL and 50 mL vials on back order and the company estimates a release date of mid- to late-May 2020. The 2 mL and 5 mL vials are on back order and the company estimates a release date of mid- to late-May 2020.
    • Hikma has fentanyl 50 mcg/mL 2 mL, 5 mL, and 50 mL vials on allocation. The 20 mL vials are on back order and the company estimates a release date of late-May 2020.
    • Pfizer has fentanyl 50 mcg/mL 20 mL and 50 mL vials on back order and the company estimates a release date of May 2020. The 5 mL and 10 mL vials are on back order and the company estimates a release date of May 2020 for the 5 mL vials and August 2020 for the 10 mL vials. The 2 mL vials and 5 mL ampules are available in limited supply. The 2 mL Carpuject syringes are on back order and the company estimates a release date of January 2023.

Implications for Patient Care

    • ASHP has an FAQ on the injectable opioid shortage at https://www.ashp.org/Drug-Shortages/Shortage-Resources/Injectable-Opioid-Shortages-FAQ. This discusses multiple issues including inventory and pharmacy operational strategies.

Updated

Updated May 12, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 8, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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