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Methylprednisolone Acetate Injection

[13 August 2014]

Products Affected - Description

Depo-Medrol injection, Pfizer
40 mg/mL, 1 mL vials (NDC 00009-3073-01)
40 mg/mL, 1 mL vials, packages of 25 (NDC 00009-3073-03)
80 mg/mL, 1 mL vials, packages of 25 (NDC 00009-3475-03)
 
Methylprednisolone acetate injection, Sandoz
40 mg/mL, 1 mL vials (NDC 00781-3131-71)
40 mg/mL, 1 mL vials, packages of 10 (NDC 00781-3131-95)
40 mg/mL, 10 mL vials (NDC 00781-3136-70)
80 mg/mL, 1 mL vials (NDC 00781-3132-71)
80 mg/mL, 1 mL vials, packages of 10 (NDC 00781-3132-95)
80 mg/mL, 5 mL vials (NDC 00781-3137-75)

Methylprednisolone acetate injection, Teva
40 mg/mL, 1 mL vials (NDC 00703-0031-01)
40 mg/mL, 1 mL vials, packages of 25 (NDC 00703-0031-04)
40 mg/mL, 10 mL vials (NDC 00703-0045-01)
80 mg/mL, 5 mL vials (NDC 00703-0063-01)

Reason for the Shortage

  • Sandoz and Teva could not provide a reason for the shortage.
  • Pfizer had Depo-Medrol injection on shortage due to manufacturing delay.

Available Products

Depo-Medrol injection, Pfizer
20 mg/mL, 5 mL vials (NDC 00009-0274-01)
40 mg/mL, 5 mL vials (NDC 00009-0280-02)
40 mg/mL, 5 mL vials, packages of 25 (NDC 00009-0280-51)

40 mg/mL, 10 mL vials (NDC 00009-0280-03)
40 mg/mL, 10 mL vials, packages of 25 (NDC 00009-0280-52)
80 mg/mL, 1 mL vials (NDC 00009-3475-01)
80 mg/mL 5 mL vials (NDC 00009-0306-02)
80 mg/mL 5 mL vials, packages of 25 (NDC 00009-0306-12)
 
Methylprednisolone acetate injection, Teva
40 mg/mL, 5 mL vials (NDC 00703-0043-01)
80 mg/mL, 1 mL vials (NDC 00703-0051-01)
80 mg/mL, 1 mL vials, packages of 25 (NDC 00703-0051-04)

Estimated Resupply Dates

  • Pfizer has Depo-Medrol 40 mg/mL 1 mL single vial packages and 80 mg/mL 1 mL vials in 25 count packages on back order with an estimated release date of late-August 2014. Pfizer has Depo-Medrol 40 mg/mL 1 mL vials in 25 count packages on back order with an estimated release date of mid-August 2014.
  • Sandoz has methylprednisolone acetate injection on long-term back order and the company cannot estimate a release date.
  • Teva has methylprednisolone acetate injection 40 mg/mL 10 mL vials and 80 mg/mL 5 mL vials on back order and the company estimates a release date in October 2014. Teva does have methylprednisolone acetate injection 40 mg/mL 10 mL vials available with short expiration dating (October 2014). Methylprednisolone acetate injection 40 mg/mL 1 mL vials are on back order and the company estimates a release date in 3rd quarter 2015.

Implications for Patient Care

  • FDA closed New England Compounding Company in Massachusetts due to a fungal meningitis outbreak linked to methylprednisolone acetate injections compounded by this pharmacy.
  • All commercially available products contain a preservative such as myristyl gamma picolinium chloride or benzyl alcohol.
  • Methylprednisolone acetate is not approved for epidural administration and contraindicated for intrathecal use.

Related Shortages

Updated

August 13, 2014; July 31, 2014; July 15, 2014; June 30, 2014; June 19, 2014; April 24, 2014; March 17, 2014; March 11, 2014; February 3, 2014; January 15, 2014; November 14, 2013; September 26, 2013; August 22, 2013; August 6, 2013; July 23, 2013; July 16, 2013; May 3, 2013; April 19, 2013; March 15, 2013; January 22, 2013; November 20, 2012; November 16, 2012; October 5, 2012; September 26, 2012; August 21, 2012; July 26, 2012; July 9, 2012; June 20, 2012; May 22, 2012, University of Utah, Drug Information Service. Copyright 2014, 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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