FDA recall D-0372-2025

Denver Solutions, LLC DBA Leiters Health · Class II · drug

Product

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,

Reason for recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Distribution

Nationwide in the U.S.A

Key facts

Status: Ongoing
Initiation date: 2025-03-31
Report date: 2025-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0372-2025