Denver Solutions, LLC DBA Leiters Health: Drug Recall

Recall #D-0372-2025 · 03/31/2025

Class II: Risk

Recall Details

Recall Number
D-0372-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Denver Solutions, LLC DBA Leiters Health
Status
Ongoing
Date Initiated
03/31/2025
Location
Englewood, CO, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,290 syringes

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Product Description

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,

Distribution Pattern

Nationwide in the U.S.A

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.