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Steroid Shortage

 

The U.S. Food and Drug Administration announced that there is a new drug shortage of a steroid.

An increase in demand and a manufacturing delay have prompted the shortage of methylprednisolone sodium succinate for injection, USP.

Fresenius Kabi estimates that its products that are currently backordered will be released in April. 

Product

Company

Reason for Shortage

40 mg, Single Dose Vial (NDC 63323-255-03)

Fresenius Kabi

Increased demand

125 mg, Single Dose Vial (NDC 63323-258-03)

Fresenius Kabi

Increased demand

Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection Rx 40 mg 1 mL ACT-O-VIAL® (NDC 0009-0039-28)

Pfizer

Manufacturing delay

Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection Rx 125 mg 2 mL ACT-O-VIAL® (NDC 0009-0047-22)

Pfizer

Manufacturing delay

However, the following products made by Pfizer are available:

  • Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection Rx 500 mg 4 mL ACT-O-VIAL® (NDC 0009-0003-02);
  • Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection Rx 1 gm 8 mL ACT-O-VIAL® (NDC 0009-0758-01);    
  • Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection Rx 1 gm 8 mL ACT-O-VIAL® (NDC 0009-0018-20);    
  • Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection Rx 1 gm 16 mL Vial (NDC 0009-0698-01);
  • Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection Rx 2 gm Vial w/Diluent (NDC 0009-0796-01);           
  • Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection for NovaPlus® Rx 40 mg 1 mL ACT-O-VIAL (NDC 0009-0039-32);      
  • Solu-Medrol® (methylprednisolone sodium succinate, USP) Sterile Powder for Injection for NovaPlus® Rx 125 mg 2 mL ACT-O-VIAL® (NDC 0009-0047-26).        

Fresenius Kabi reported that the following presentation is available:

  • 1 g, Single Dose Vial (NDC 63323-265-30).         

Click here to read the full report.

 

--Stephanie Vaccaro

 

Reference:

1. U.S. Food and Drug Administration. FDA drug shortages. www.fda.gov. Accessed March 14, 2016.