FDA-Drug2024-02-07Class I
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
Hazard
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Sold states
Nationwide within the United States
Affected count
12,564 IV bags
Manufactured in
13796 Compark Blvd, Englewood, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0280-2024Don't want to check this manually?
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