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6/26/2020

Argatroban Injection

Products Affected - Description

    • Argatroban intravenous injection, Mylan Institutional, 100 mg/mL, 2.5 mL vial, 1 count, NDC 67457-0212-02
    • Argatroban intravenous injection, Pfizer, 100 mg/mL, 2.5 mL vial, 1 count, NDC 00409-1140-01
    • Argatroban intravenous injection, Sandoz, 1 mg/mL, 125 mL vial, 2 count, NDC 00781-3285-12 - discontinued
    • Argatroban intravenous injection, Sandoz, 1 mg/mL, 50 mL vial, 10 count, NDC 00781-3314-95 - discontinued
    • Argatroban intravenous injection, Teva, 1 mg/mL, 250 mL premixed bag, 5 count, NDC 00703-0020-32

Reason for the Shortage

    • AuroMedics has argatroban available.
    • Chiesi has argatroban available.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Hikma has argatroban available.
    • Mylan Institutional did not provide a reason for the shortage.
    • Par has argatroban available.
    • Pfizer did not provide a reason for the shortage.
    • Sandoz discontinued argatroban 1 mg/mL 50 mL vials in April 2019. Sandoz discontinued argatroban 1 mg/mL 125 mL vials in April 2020.
    • Teva has argatroban temporarily unavailable.

Available Products

    • Argatroban intravenous injection, AuroMedics, 1 mg/mL, 50 mL vial, 10 count, NDC 55150-0241-10
    • Argatroban intravenous injection, Chiesi, 1 mg/mL, 50 mL vial, 10 count, NDC 42367-0203-84
    • Argatroban intravenous injection, Fresenius Kabi, 100 mg/mL, 2.5 mL vial, 1 count, NDC 63323-0526-03
    • Argatroban intravenous injection, Hikma, 1 mg/mL, 50 mL vial, 1 count, NDC 00143-9559-01
    • Argatroban intravenous injection, Hikma, 100 mg/mL, 2.5 mL vial, 1 count, NDC 00143-9674-01
    • Argatroban intravenous injection, Novartis, 100 mg/mL, 2.5 mL vial, 1 count, NDC 00078-0930-61
    • Argatroban intravenous injection, Par Pharmaceuticals, 100 mg/mL, 2.5 mL vial, 1 count, NDC 42023-0182-01

Estimated Resupply Dates

    • Mylan has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a release date of late-June 2020.
    • Pfizer has argatroban 100 mg/mL 2.5 mL vials available in limited supply.
    • Teva has temporarily discontinued argatroban 1 mg/mL 250 mL premixed bags.

Updated

Updated June 26, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 20, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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