Public recall detail

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

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Recall Safety notice
Quick summary

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

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

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

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

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.

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