Class I

Drug Recall: PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.

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

12,564 IV bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0280-2024

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.