Class IIReported 2025-04-30

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,

Recalled by Denver Solutions, LLC DBA Leiters Health

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Recall Number

D-0372-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-31

Reported

2025-04-30

Distribution

Nationwide in the U.S.A

Code Info

Lot #: 2431349A, Exp.: 6/16/2025

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.