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Rho(D) Immune Globulin (Human) Shortage

Last Updated: June 30, 2025
Status: Current

Products Affected - Description
    • RhoGAM Ultra-Filtered Plus intramuscular injection, Kedrion Biopharma, Inc., 1,500 units (300 mcg), syringe, 1 count, NDC 00562-7805-01
    • Rhophylac injection, CSL Behring, 1,500 units (300 mcg), 2 mL syringe, 10 count, NDC 44206-0300-10 - discontinued
    • WinRho SDF injection, Kamada, 5,000 units (1,000 mcg)/4.4 mL, vial, 1 count, NDC 49591-0310-51 - discontinued
Reason for the Shortage
    • CSL Behring has Rhophylac available to current customer and some extra for new customers depending on demand at any given time. They discontinued the 10-count presentation in August 2024.
    • Grifols has HyperRHO S/D Full Dose injection available.
    • Kedrion has RhoGAM on shortage due to the shortage of an active ingredient and manufacturing issues and plant maintenance requirements.
    • Kamada has discontinued WinRho SDF 5,000 units (1,000 mcg)/4.4 mL vials (NDC 49591-0310-51) and the company will be distributing product until August 2025. All presentations of WinRho SDF have the same concentration. There is a letter describing how to dose WinRho SDF with different vial sizes at https://www.kamada.com/wp-content/uploads/2024/05/WINRHO-DHCP-letter-May-2024.pdf
Available Products
    • HyperRHO S/D Full Dose intramuscular injection, Grifols, 1,500 units (300 mcg), syringe, 1 count, NDC 13533-0631-02
    • HyperRHO S/D Full Dose intramuscular injection, Grifols, 1,500 units (300 mcg), syringe, 10 count, NDC 13533-0631-11
    • RhoGAM Ultra-Filtered Plus intramuscular injection, Kedrion Biopharma, Inc., 1,500 units (300 mcg), syringe, 5 count, NDC 00562-7805-05
    • RhoGAM Ultra-Filtered Plus intramuscular injection, Kedrion Biopharma, Inc., 1,500 units (300 mcg), syringe, 25 count, NDC 00562-7805-25
    • Rhophylac injection, CSL Behring, 1,500 units (300 mcg), 2 mL syringe, 1 count, NDC 44206-0300-01
    • WinRho SDF injection, Kamada, 1,500 units (300 mcg)/1.3 mL, vial, 1 count, NDC 49591-0330-51
    • WinRho SDF, Kamada, 5,000 units (1,000 mcg)/4.4 mL, vial, 1 count, NDC 49591-0300-51

Estimated Resupply Dates

    • Kedrion has RhoGAM Ultra-Filtered Plus 1,500 units (300 mcg) syringes in 1 count on back order and the company cannot estimate a release date.
    • Kamada has discontinued WinRho SDF 5,000 units (1,000 mcg)/4.4 mL vials (NDC 49591-0310-51) and the company will be distributing product until August 2025.

Updated

Updated June 30, 2025 by Leslie Jensen, PharmD, Drug Information Specialist. Created January 10, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

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