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FDARecalled Apr 30, 2025 · #D-0372-2025

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,

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility: Leaking/damaged syringes. Classification: Class II Distribution: Nationwide in the U.S.A

Product details

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,
Type
Drugs
Manufacturer
Denver Solutions, LLC DBA Leiters Health
Model numbers
2431349A
UPCs