Product: 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,
Reason for recall: Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated: 20250331
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated