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.
Reported: February 7, 2024 Initiated: December 28, 2023 #D-0280-2024
Product Description
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.
Reason for Recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Details
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Units Affected
- 12,564 IV bags
- Distribution
- Nationwide within the United States
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Denver Solutions, LLC DBA Leiters Health. Units affected: 12,564 IV bags.
Why was this product recalled? ▼
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2024. Severity: Critical. Recall number: D-0280-2024.
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