← FDA ENFORCEMENT
D-0372-2025Class II

Denver Solutions, LLC DBA Leiters Health

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Denver Solutions, LLC DBA Leiters Health
Product type
Drug
Status
Ongoing
Report date
2025-04-30
Distribution
Nationwide in the U.S.A
Firm state
CO
Product quantity
7,290 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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,

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →