Drug product
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.
D-0280-2024
Product summary
- Event
- Event 93710
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 12,564 IV bags
- Official record key
drug-enforcement:D-0280-2024
Official wording
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Code information: Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Superpotent