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

• • 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.