4/7/2024

Fentanyl Citrate Injection

Products Affected - Description

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

Reason for the Shortage

- Akorn ceased operations in February 2023.
- Fresenius Kabi has fentanyl on shortage due to manufacturing delays.
- 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 available.

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, 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, 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, 20 mL vial, 1 count, NDC 00641-6029-01
- 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 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 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

Estimated Resupply Dates

- Fresenius Kabi has fentanyl 50 mcg/mL 2 mL vials on back order and the company estimates a release date of mid-May 2024.
- Hikma has fentanyl 50 mcg/mL 50 mL vials on back order and the company estimates a release date of late-April to early-May 2024. There are short-dated 5 mL vials available with an expiration date of January 2025.

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 7, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 8, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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