PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,

Recall Number: D-0372-2025

Firm: Denver Solutions, LLC DBA Leiters Health

Classification: Class II

Status: Ongoing

Report Date: 20250430

Initiation Date: 20250331

Termination Date:

Lack of Assurance of Sterility: Leaking/damaged syringes.

PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,