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7/7/2022

Busulfan Injection

Products Affected - Description

    • Busulfan intravenous injection, Armas Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 72485-0210-08
    • Busulfan intravenous injection, Fresenius Kabi, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 65219-0160-10

Reason for the Shortage

    • Amneal has busulfan injection available.
    • Armas Pharmaceuticals did not provide a reason for the shortage.
    • Athenex is not currently marketing busulfan injection.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Meitheal Pharmaceuticals has busulfan available.
    • Mylan Institutional has busulfan injection available.
    • Sagent has busulfan injection available.
    • Otsuka has Busulfex available.

Available Products

    • Busulfex intravenous injection, Otsuka America Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 59148-0070-91
    • Busulfan intravenous injection, Amneal, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 70121-1244-07
    • Busulfan intravenous injection, Meitheal Pharmaceuticals, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 71288-0116-11
    • Busulfan intravenous injection, Mylan, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 67457-0893-08
    • Busulfan intravenous injection, Sagent, 6 mg/mL, 10 mL single dose vial, 8 count, NDC 25021-0241-10

Estimated Resupply Dates

    • Armas has busulfan 6 mg/mL 10 mL vials on long-term back order and the company cannot estimate a release date.
    • Fresenius Kabi has short-dated busulfan 6 mg/mL 10 mL vials available with an expiration date of < 1 month.

Updated

Updated July 7, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. Created January 4, 2019 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. © 2022, 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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