Class I

Drug Recall: 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.

Denver Solutions, LLC DBA Leiters Health · December 28, 2023

Reason for Recall

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

29,016 IV bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0279-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Denver Solutions, LLC DBA Leiters Health Drug Recall: 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. | SafeCheck