Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL) Recalled by Denver Solutions, LLC DBA Leiters Health Due to Superpotent Drug: semi-automated IV bag filling system can...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Denver Solutions, LLC DBA Leiters Health directly.
Affected Products
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
Quantity: 29,016 IV bags
Why Was This Recalled?
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Denver Solutions, LLC DBA Leiters Health
Denver Solutions, LLC DBA Leiters Health has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report