PHENYLephrine HCl in 0 recalled over sterility concerns

Recall date

March 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Heal…

Recall number

D-0372-2025

FDA classification

Class II

Brand / firm

Denver Solutions, LLC DBA Leiters Health

Sold / distributed

Nationwide in the U.S.A

Why it was recalled

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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,