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Methotrexate Injection

[15 May 2015]

Products Affected - Description

Methotrexate injection, Accord Healthcare
25 mg/mL, 2 mL vial, preservative-free, single-count (NDC 16729-0277-30)
25 mg/mL, 10 mL vial, preservative-free (NDC 16729-0277-03)
25 mg/mL, 40 mL preservative-free vial (NDC 16729-0277-35)

Methotrexate injection, Mylan Institutional
25 mg/mL, 2 mL vial, preservative-free, 5 count (NDC 67457-0467-99)
25 mg/mL, 4 mL vial, preservative-free, 10 count (NDC 67457-0486-99)
25 mg/mL, 8 mL vial, preservative-free, 10 count (NDC 67457-0485-99)
25 mg/mL, 10 mL vial, preservative-free, single-count (NDC 67457-0466-10)
25 mg/mL, 40 mL vial, preservative-free, single-count (NDC 67457-0480-40)

Methotrexate injection, Sandoz
25 mg/mL, 2 mL vial, preservative-free, 10 count (NDC 66758-0040-02) - discontinued
25 mg/mL, 10 mL vial, preservative-free, 10 count (NDC 66758-0040-08) - discontinued
 
Methotrexate injection, Teva
25 mg/mL, 40 mL vial, preservative-free, single-count (NDC 00703-3678-01)

Reason for the Shortage

  • Mylan Institutional cannot provide a reason for the shortage.
  • Sandoz discontinued methotrexate 2 mL and 10 mL vials.
  • West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including methotrexate injection. West-Ward is not actively marketing methotrexate injection.
  • Teva has methotrexate on short-term back order for standard quality control.

Available Products

Methotrexate (with preservative), Fresenius Kabi
25 mg/mL, 10 mL (with preservative) vial, single-count (NDC 63323-0123-10)

Methotrexate lyophilized powder for injection, Fresenius Kabi
1 gram vial, single-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, single-count (NDC 61703-0408-41)

Methotrexate injection, Sandoz
25 mg/mL, 40 mL vial, preservative-free, single-count (NDC 66758-0041-01)

Methotrexate injection, Teva
25 mg/mL, 2 mL vial, preservative-free, 10 count (NDC 00703-3671-03)
25 mg/mL, 10 mL vial, preservative-free, single-count (NDC 00703-3675-01)

Otrexup subcutaneous injection, Antares Pharm, Inc.
10 mg/0.4 mL auto-injector, 4 count (NDC 54436-0010-04)
15 mg/0.4 mL auto-injector, 4 count (NDC 54436-0015-04)
20 mg/0.4 mL auto-injector, 4 count (NDC 54436-0020-04)
25 mg/0.4 mL auto-injector, 4 count (NDC 54436-0025-04)

Estimated Resupply Dates

  • Accord has methotrexate 10 mL and 40 mL vials on back order and the company cannot estimate a release date. Methotrexate 2 mL vials are available with short expiration dating (February 2016).
  • Mylan Institutional has all methotrexate presentations on back order and the company cannot estimate a release date.
  • Sandoz has discontinued methotrexate 25 mg/mL 2 mL and 10 mL vials.
  • Teva has methotrexate 25 mg/mL 40 mL vials on back order and the company estimates a release date of late-May 2015.

Related Shortages

Updated

May 15, April 15, March 11 and 26, February 11 and 18, January 26, 2015; December 3, 12, and 22, November 20, October 29, September 5, 18, and 24, August 1 and 13, July 2, June 5 and 19, May 14 and 22, April 3 and 30, March 3 and 20, February 6, and January 24, 2014; December 9 and 20, November 6 and 19, September 12, July 16, June 19, May 30, April 3, March 4, February 13, and January 4, 18, and 30, 2013; December 12 and 18, October 4 and 11, August 2 and 27, July 13, June 21, May 24, April 13 and 23, March 13 and 26, February 8, 10, 13,14,16, 22, 24, and 29, 2012. University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation 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. Novation, 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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