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5/16/2023

Epoprostenol Injection and Sterile Diluent

Products Affected - Description

    • Epoprostenol sodium lyophilized powder for injection, Teva, 0.5 mg, single dose vial, NDC 00703-1985-01
    • Epoprostenol sodium lyophilized powder for injection, Teva, 1.5 mg, single dose vial, NDC 00703-1995-01
    • Sterile diluent for epoprostenol sodium, Teva, 94 mg glycine - 73.5 mg sodium chloride / 50 mL, 50 mL vial, 2 count, NDC 00703-9258-09

Reason for the Shortage

    • Actelion Pharmaceuticals has Veletri available.
    • GSK has Flolan available. The pH 12 Sterile Diluent for Flolan is available through Curascript specialty pharmacy for customers with a recent purchase history of Flolan.
    • Sun Pharma has epoprostenol injection available.
    • Teva has epoprostenol injection and sterile diluent temporarily unavailable due to limited production capacity. Epoprostenol and sterile diluent will be temporarily unavailable for an extended period.

Available Products

    • Flolan lyophilized powder for injection, GSK, 0.5 mg, single dose vial, NDC 00173-0517-00
    • Flolan lyophilized powder for injection, GSK, 1.5 mg, single dose vial, NDC 00173-0519-00
    • Veletri lyophilized powder for injection, Actelion Pharmaceuticals, 0.5 mg, single dose vial, NDC 66215-0403-01
    • Veletri lyophilized powder for injection, Actelion Pharmaceuticals, 1.5 mg, single dose vial, NDC 66215-0402-01
    • Epoprostenol sodium lyophilized powder for injection, Sun Pharma, 0.5 mg, single dose vial, NDC 62756-0059-40
    • Epoprostenol sodium lyophilized powder for injection, Sun Pharma, 1.5 mg, single dose vial, NDC 62756-0060-40
    • pH 12 Sterile Diluent for Flolan, GSK, 94 mg glycine - 73.5 mg sodium chloride / 50 mL, 50 mL vial, 2 count, NDC 00173-0857-02

Estimated Resupply Dates

    • Teva has epoprostenol sodium 0.5 mg vials, 1.5 mg vials, and sterile diluent temporarily unavailable and the company cannot estimate a release date. Epoprostenol and sterile diluent will be temporarily unavailable for an extended period.

Updated

Updated May 16, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. Created September 15, 2021 by Stephen Andrews, PharmD, BCPS, CPPS, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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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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