FDA Drug Class II — Moderate

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

Lack of Assurance of Sterility: Leaking/damaged syringes.

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Products

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,
Brand
Denver Solutions, LLC DBA Leiters Health
UPC
Lot #: 2431349A, Exp.: 6/16/2025

Units Affected

7,290 syringes

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