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6/27/2017

Methylprednisolone Acetate Injection

Products Affected - Description

    • Methylprednisolone Acetate injection, Sandoz, 40 mg/mL, 1 mL vial, 1 count, NDC 00781-3131-71
    • Methylprednisolone Acetate injection, Sandoz, 40 mg/mL, 1 mL vial, 10 count, NDC 00781-3131-95
    • Methylprednisolone Acetate injection, Sandoz, 40 mg/mL, 10 mL vial, 1 count, NDC 00781-3136-70
    • Methylprednisolone Acetate injection, Sandoz, 80 mg/mL, 1 mL vial, 1 count, NDC 00781-3132-71
    • Methylprednisolone Acetate injection, Sandoz, 80 mg/mL, 1 mL vial, 10 count, NDC 00781-3132-95
    • Methylprednisolone Acetate injection, Sandoz, 80 mg/mL, 5 mL vial, 1 count, NDC 00781-3137-75

Reason for the Shortage

    • Sandoz could not provide a reason for the shortage.
    • Pfizer had Depo-Medrol injection on a short-term shortage due to increased demand of Solu-Medrol.
    • Teva is not actively marketing methylprednisolone acetate.

Available Products

    • Depo-Medrol injection, Pfizer, 20 mg/mL, 5 mL vial, 1 count, NDC 00009-0274-01
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 1 mL vial, 1 count, NDC 00009-3073-01
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 1 mL vial, 25 count, NDC 00009-3073-03
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 10 mL vial, 1 count, NDC 00009-0280-03
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 10 mL vial, 25 count, NDC 00009-0280-52
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 5 mL vial, 1 count, NDC 00009-0280-02
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 5 mL vial, 25 count, NDC 00009-0280-51
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 1 mL vial, 1 count, NDC 00009-3475-01
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 1 mL vial, 25 count, NDC 00009-3475-03
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 5 mL vial, 1 count, NDC 00009-0306-02
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 5 mL vial, 25 count, NDC 00009-0306-12

Estimated Resupply Dates

    • Sandoz has methylprednisolone acetate injection temporarily unavailable and the company cannot estimate a release date.

Implications for Patient Care

    • FDA closed New England Compounding Company in Massachusetts due to a fungal meningitis outbreak linked to methylprednisolone acetate injections compounded by this pharmacy. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322849.htm?source=govdelivery.
    • All commercially available products contain a preservative such as myristyl gamma picolinium chloride or benzyl alcohol.
    • Methylprednisolone acetate is not approved for epidural administration and contraindicated for intrathecal use.

Updated

Updated June 27, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 22, 2012 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, 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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