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8/7/2019

Hydroxyprogesterone Caproate Injection

Products Affected - Description

    • Makena intramuscular solution for injection, AMAG, 250 mg/mL, 1 mL single dose vial, NDC 64011-0247-02
    • Makena intramuscular solution for injection, AMAG, 250 mg/mL, 5 mL multiple dose vial, NDC 64011-0243-01
    • Hydroxyprogesterone caproate intramuscular solution for injection, Prasco, 250 mg/mL, 5 mL multiple dose vial, NDC 66993-0039-01 - discontinued

Reason for the Shortage

    • AMAG has Makena vials on shortage due to manufacturing delay.
    • American Regent has hydroxyprogesterone injection available.
    • AuroMedics has hydroxyprogesterone injection available.
    • Mylan has hydroxyprogesterone injection available.
    • Prasco discontinued the 5 mL vials in mid-2019. Prasco has hydroxyprogesterone 1 mL vials available.
    • Slayback Pharma launched hydroxyprogesterone injection in early 2019.

Available Products

    • Makena subcutaneous solution for injection, AMAG, 275 mg/1.1 mL, 1.1 mL auto-injector, NDC 64011-0301-03
    • Hydroxyprogesterone caproate intramuscular solution for injection, American Regent, 250 mg/mL, 1 mL vial, NDC 00517-1767-01
    • Hydroxyprogesterone caproate intramuscular solution for injection, AuroMedics, 250 mg/mL, 1 mL single dose vial, NDC 55150-0309-01
    • Hydroxyprogesterone caproate intramuscular solution for injection, AuroMedics, 250 mg/mL, 5 mL multiple dose vial, NDC 55150-0310-01
    • Hydroxyprogesterone caproate intramuscular solution for injection, Mylan, 250 mg/mL, 5 mL multiple dose vial, NDC 67457-0886-05
    • Hydroxyprogesterone caproate intramuscular solution for injection, Prasco, 250 mg/mL, 1 mL single dose vial, NDC 66993-0038-83
    • Hydroxyprogesterone caproate intramuscular solution for injection, Slayback Pharma, 250 mg/mL, 1 mL single dose vial, NDC 71225-0105-01
    • Hydroxyprogesterone caproate intramuscular solution for injection, Slayback Pharma, 250 mg/mL, 5 mL multiple dose vial, NDC 71225-0104-01

Estimated Resupply Dates

    • AMAG has Makena 250 mg/mL 1 mL and 5 mL vials on back order and the company cannot estimate a release date.

Updated

Updated August 7, 2019 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. Created December 10, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, 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, which 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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