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12/21/2022

Methylprednisolone Acetate Injection

Products Affected - Description

    • Depo-Medrol injection, Pfizer, 20 mg/mL, 5 mL multiple dose vial, 1 count, NDC 00009-0274-01
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 5 mL multiple dose vial, 1 count, NDC 00009-0280-02
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 5 mL multiple dose vial, 25 count, NDC 00009-0280-51
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 1 mL single dose vial, 25 count, NDC 00009-3475-03
    • Methylprednisolone Acetate injection, Sagent, 40 mg/mL, 10 mL multiple dose vial, 1 count, NDC 25021-0820-10
    • Methylprednisolone Acetate injection, Sagent, 40 mg/mL, 5 mL multiple dose vial, 1 count, NDC 25021-0820-05
    • Methylprednisolone Acetate injection, Teva, 40 mg/mL, 1 mL single dose vial, 1 count, NDC 00703-0031-01
    • Methylprednisolone Acetate injection, Teva, 40 mg/mL, 1 mL single dose vial, 25 count, NDC 00703-0031-04
    • Methylprednisolone Acetate injection, Teva, 40 mg/mL, 10 mL multiple dose vial, 1 count, NDC 00703-0045-01
    • Methylprednisolone Acetate injection, Teva, 40 mg/mL, 5 mL multiple dose vial, 1 count, NDC 00703-0043-01
    • Methylprednisolone Acetate injection, Teva, 80 mg/mL, 1 mL single dose vial, 1 count, NDC 00703-0051-01
    • Methylprednisolone Acetate injection, Teva, 80 mg/mL, 1 mL single dose vial, 25 count, NDC 00703-0051-04
    • Methylprednisolone Acetate injection, Teva, 80 mg/mL, 5 mL multiple dose vial, 1 count, NDC 00703-0063-01

Reason for the Shortage

    • Amneal is actively shipping allocated methylprednisolone acetate single dose vials on historical demand.[1]
    • Pfizer has Depo-Medrol on shortage due to increased demand and manufacturing delays.[2]
    • Sagent has methylprednisolone acetate injection available.[3]
    • Teva did not provide a reason for the shortage.[4]

Available Products

    • Depo-Medrol injection, Pfizer, 40 mg/mL, 1 mL single dose vial, 1 count, NDC 00009-3073-01
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 1 mL single dose vial, 25 count, NDC 00009-3073-03
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 10 mL multiple dose vial, 1 count, NDC 00009-0280-03
    • Depo-Medrol injection, Pfizer, 40 mg/mL, 10 mL multiple dose vial, 25 count, NDC 00009-0280-52
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 1 mL single dose vial, 1 count, NDC 00009-3475-01
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 5 mL multiple dose vial, 1 count, NDC 00009-0306-02
    • Depo-Medrol injection, Pfizer, 80 mg/mL, 5 mL multiple dose vial, 25 count, NDC 00009-0306-12
    • Methylprednisolone Acetate injection, Amneal, 40 mg/mL, 1 mL single dose vial, 1 count, NDC 70121-1573-01
    • Methylprednisolone Acetate injection, Amneal, 40 mg/mL, 1 mL single dose vial, 25 count, NDC 70121-1573-05
    • Methylprednisolone Acetate injection, Amneal, 80 mg/mL, 1 mL single dose vial, 1 count, NDC 70121-1574-01
    • Methylprednisolone Acetate injection, Amneal, 80 mg/mL, 1 mL single dose vial, 25 count, NDC 70121-1574-05
    • Methylprednisolone Acetate injection, Sagent, 80 mg/mL, 5 mL multiple dose vial, 1 count, NDC 25021-0821-05

Estimated Resupply Dates

    • Sagent has methylprednisolone acetate 40 mg/mL 1 mL and 5 mL vials on allocation.
    • Teva has all presentations of methylprednisolone acetate on back order and the company cannot estimate a release date.
    • Pfizer has Depo-Medrol 20 mg/mL 5 mL vials in 1 count on back order and the company estimates a release date of December 2022. The 40 mg/mL 5 mL vials in 1 count and 25 count are on back order with an estimated release date of January 2023 for the 1 count and December 2022 for the 25 count. The 80 mg/mL 1 mL vials in 25 count are available in limited supply.

Alternative Agents & Management

    • The table below lists possible alternatives for patients who receive injectable corticosteroid suspensions.
    Table 1. Alternative agents for disorders commonly treated injectable corticosteroid suspensions.5-6
    Intra-articular injections for disorders such as rheumatoid arthritis and bursitisBetamethasone acetate/betamethasone sodium phosphate
    Intralesional injectionsTriamcinolone acetonide
    <40 mg per treatment

    Methylprednisolone acetate
    20 to 40 mg per treatment for large lesions


References

    1. Amneal (personal communication). August 20, and December 16 and 17, 2021, and August 26, 2022.
    2. Pfizer (personal communication). August 20, September 17, November 19, December 10, 2021, and July 1 and August 26, 2022.
    3. Sagent (personal communication. July 22 and August 26, 2022.
    4. Teva (personal communication). August 20, September 17, November 12, December 10, 2021, and July 1 and August 26, 2022.
    5. Lexicomp Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc; 2018.
    6. Dexamethasone sodium phosphate injection [package insert]. Lake Zurich, IL: Fresenius Kabi; 2021.

Updated

Updated December 21, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 20, 2021 by Stephen Andrews, PharmD, BCPS, CPPS, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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