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4/2/2020

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, 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, 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 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 has fentanyl 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 manufacturing delays. The 20 mL ampules were discontinued in September 2017.
    • Fresenius Kabi did not provide a reason for the shortage.

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, Fresenius Kabi, 50 mcg/mL, 2 mL vial, 25 count, NDC 63323-0806-02
    • Fentanyl citrate solution for injection, Fresenius Kabi, 50 mcg/mL, 5 mL vial, 25 count, NDC 63323-0806-05

Estimated Resupply Dates

    • Akorn has fentanyl 50 mcg/mL 2 mL ampules on back order and the company estimates a release date of mid-April 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 early- to mid-May 2020.
    • Hikma has fentanyl 50 mcg/mL 2 mL, 5 mL, 20 mL, and 50 mL vials on back order and the company estimates a release date of early-April 2020 for the 2 mL vials, late-April 2020 for the 5 mL vials, late-May 2020 for the 20 mL vials, and mid-April 2020 for the 50 mL vials.
    • Pfizer has fentanyl 50 mcg/mL 20 mL vials on back order and the company estimates a release date of April 2020. The 2 mL and 5 mL ampules are available in limited supply. The 2 mL, 5 mL, 10 mL, and 50 mL vials 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 April 2, 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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