FDARecalled Feb 7, 2024 · #D-0279-2024
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.
Hazard
Class I — serious health risk
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Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Classification: Class I Distribution: Nationwide within the United States
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Model numbers
- 2330993
- UPCs
- —