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Potassium Phosphate Injection Shortage

Last Updated: September 11, 2024
Status: Current

Products Affected - Description
    • Potassium Phosphate injection, Fresenius Kabi, 3 mmol/mL, 50 mL vial, 25 count, NDC 65219-0056-29
Reason for the Shortage
    • American Regent has potassium phosphate injection available.
    • Amneal has potassium phosphate injection available.
    • CMP Pharma has potassium phosphate injection available.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Pfizer has potassium phosphate injection available.
    • Somerset has potassium phosphate injection available.
Available Products
    • Potassium Phosphate injection, American Regent, 3 mmol/mL, 15 mL vial, 25 count, NDC 00517-2102-25
    • Potassium Phosphate injection, American Regent, 3 mmol/mL, 5 mL vial, 25 count, NDC 00517-2051-25
    • Potassium Phosphate injection, American Regent, 3 mmol/mL, 50 mL vial, 25 count, NDC 00517-2505-25
    • Potassium Phosphate injection, Amneal, 3 mmol/mL, 15 mL vial, 30 count, NDC 80830-1691-02
    • Potassium Phosphate injection, Amneal, 3 mmol/mL, 5 mL vial, 30 count, NDC 80830-1693-03
    • Potassium Phosphate injection, Amneal, 3 mmol/mL, 50 mL vial, 15 count, NDC 80830-1692-02
    • Potassium Phosphate injection, Somerset Therapeutics LLC, 3 mmol/mL, 15 mL vial, 25 count, NDC 70069-0747-25
    • Potassium Phosphate injection, Somerset Therapeutics LLC, 3 mmol/mL, 5 mL vial, 25 count, NDC 70069-0746-25
    • Potassium Phosphate injection, CMP Pharma, 3 mmol/mL, 15 mL vial, 10 count, NDC 46287-0024-10
    • Potassium Phosphate injection, Fresenius Kabi, 3 mmol/mL, 15 mL vial, 25 count, NDC 65219-0054-29
    • Potassium Phosphate injection, Fresenius Kabi, 3 mmol/mL, 5 mL vial, 25 count, NDC 65219-0052-29
    • Potassium Phosphate injection, Pfizer, 3 mmol/mL, 15 mL vial, 25 count, NDC 00409-7295-01

Estimated Resupply Dates

    • Fresenius Kabi has potassium phosphate 3 mmol/mL 50 mL vials on back order and the company cannot estimate a release date.

Safety

    • FDA continues to be concerned about the risk of aluminum toxicity associated with unapproved potassium phosphate products in pediatric patients. Pfizer (Hospira) has agreed to stop distributing their unapproved product within 90 days of August 1, 2024. There are generic products that have been approved since February 2023 that have acceptable aluminum levels. More information can be found at: https://www.fda.gov/drugs/drug-safety-and-availability/infants-risk-aluminum-toxicity-unapproved-potassium-phosphates-drug-product

Updated

Updated September 11, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 1, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

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