FDA-Drug2025-04-30Class II
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,
Denver Solutions, LLC DBA Leiters Health
Hazard
Lack of Assurance of Sterility: Leaking/damaged syringes.
Sold states
Nationwide in the U.S.A
Affected count
7,290 syringes
Manufactured in
13796 Compark Blvd, N/A, Englewood, CO, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0372-2025Don't want to check this manually?
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