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Methotrexate Injection

[16 December 2016]

Products Affected - Description

Methotrexate injection, Accord
25 mg/mL, 2 mL preservative-free vial, 1 count (NDC 16729-0277-30)
25 mg/mL, 10 mL vial, 1 count (NDC 16729-0277-03)
25 mg/mL, 40 mL preservative-free vial, 1 count (NDC 16729-0277-35)
 
Methotrexate injection, Mylan Institutional
25 mg/mL, 2 mL preservative-free vial, 5 count (NDC 67457-0467-99)
25 mg/mL, 4 mL preservative-free vial, 10 count (NDC 67457-0486-99)
25 mg/mL, 8 mL preservative-free vial, 10 count (NDC 67457-0485-99)
25 mg/mL, 10 mL preservative-free vial, 1 count (NDC 67457-0466-10)
25 mg/mL, 40 mL preservative-free vial, 1 count (NDC 67457-0480-40)
 
Methotrexate injection, Teva
25 mg/mL, 2 mL preservative-free vial, 10 count (NDC 00703-3671-03)
25 mg/mL, 10 mL preservative-free vial, 1 count (NDC 00703-3675-01)

Reason for the Shortage

  • Accord did not provide a reason for the shortage.
  • Fresenius Kabi has methotrexate injection available.
  • Mylan did not provide a reason for the shortage.
  • Teva has methotrexate on shortage due to manufacturing delays.
  • Pfizer (Hospira) has methotrexate injection available.

Available Products

Methotrexate injection, Fresenius Kabi
25 mg/mL, 10 mL (with preservative) vial, 1 count (NDC 63323-0123-10)
 
Methotrexate lyophilized powder for solution for injection, Fresenius Kabi
1 gram, vial, 1 count (NDC 63323-0122-50)

Methotrexate injection, Hospira
25 mg/mL, 2 mL (with preservative) vial, 5 count, NDC 61703-0350-38)
25 mg/mL, 40 mL preservative-free vial, 1 count, NDC 61703-0408-41)
 
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 vials on back order and the company estimates a release date of late-January 2017.
  • Mylan Institutional has methotrexate injection temporarily unavailable and the company cannot estimate a release date.
  • Teva has methotrexate 25 mg/mL 2 mL and 10 mL vials on intermittent back order and the company is releasing product as it becomes available.

Related Shortages

Updated

December 16, 2016, University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, 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, which 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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