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3/14/2023

Methotrexate Injection

Products Affected - Description

    • Methotrexate injection, Accord, 25 mg/mL, 10 mL preservative-free vial, 1 count, NDC 16729-0277-03
    • Methotrexate injection, Accord, 25 mg/mL, 2 mL preservative-free vial, 1 count, NDC 16729-0277-30
    • Methotrexate injection, Accord, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 16729-0277-35
    • Methotrexate injection, Fresenius Kabi, 25 mg/mL, 10 mL (with preservative) vial, 1 count, NDC 63323-0123-10
    • Methotrexate, Fresenius Kabi, 1 gram, vial, 1 count, NDC 63323-0122-50
    • Methotrexate injection, Hikma, 25 mg/mL, 2 mL preservative-free vial, 10 count, NDC 00143-9519-10
    • Methotrexate, Hikma, 1 gram, vial, 1 count, NDC 00143-9830-01
    • Methotrexate injection, Pfizer, 25 mg/mL, 2 mL (with preservative) vial, 5 count, NDC 61703-0350-38
    • Methotrexate injection, Pfizer, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 61703-0408-41
    • Methotrexate injection, Teva, 25 mg/mL, 10 mL preservative-free vial, 1 count, NDC 00703-3675-01
    • Methotrexate injection, Teva, 25 mg/mL, 2 mL preservative-free vial, 1 count, NDC 00703-3671-01

Reason for the Shortage

    • Accord has methotrexate injection on manufacturing back order.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Pfizer has methotrexate injection on back order due to manufacturing delay.
    • Teva did not provide a reason for the shortage.
    • Hikma did not provide a reason for the shortage.

Available Products

    • Methotrexate injection, Teva, 25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 00703-3678-01

Estimated Resupply Dates

    • Accord has methotrexate 25 mg/mL 2 mL, 10 mL, and 40 mL preservative-free vials on back order and the company cannot estimate a release date.
    • Fresenius Kabi has methotrexate 25 mg/mL 10 mL preservative-free vials and 1 gram lyophilized powder vials on back order with an estimated release date of late-May to early-June 2023.
    • Hikma has methotrexate 1 gram lyophilized powder vials on back order and the company estimates a release date of late-March to early-April 2023. The 25 mg/mL 2 mL preservative-free vials are on back order and the company estimates a release date of mid-March 2023.
    • Pfizer has methotrexate 25 mg/mL 2 mL vials and 40 mL preservative-free vials available in limited supply.
    • Teva has methotrexate 25 mg/mL 2 mL preservative-free vials on back order and the company estimates a release date in May 2023. There are short-dated 10 mL preservative-free vials available with an expiration date of July 2023.

Updated

Updated March 14, 2023 by Michelle Wheeler, PharmD, Drug Information Specialist. Created February 2, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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