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Health Canada Health products

Solu-Cortef (hydrocortisone sodium succinate for injection) 100 mg/2 mL single-dose Act-O-Vial - Recalled Lots due to Potential for Dosing Error

Issued August 2, 2016
Issue
Solu-Cortef (hydrocortisone sodium succinate for injection) 100 mg /2 mL single-dose Act-O-Vial has a labelling text error on the side panel of the carton. It indicates that the reconstituted product contains 125 mg/mL hydrocortisone instead of 50 mg/mL (see visual below). This labelling error on the carton has resulted in a product recall which in turn has generated a supply shortage of Solu-Cortef (hydrocortisone sodium succinate for injection) 100 mg/2 mL single-dose Act-O-Vial. During the temporary shortage, the use of the 250 mg/2 mL or the 500 mg/4 mL Solu-Cortef Act-O-Vials (with appropriate adjustment to the volume of the dose), or alternate products,1 should be considered. The concentration displayed on the front panel of the carton, the vial label and the product leaflets are all correct.
Hazard description
Product safety