Drug product
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
D-0282-2024
Product summary
- Event
- Event 93710
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 7,548 IV bags
- Official record key
drug-enforcement:D-0282-2024
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 #: 2331140, Exp. Date 02/08/2024; 2331188, Exp. Date 02/15/2024; 2331261, Exp. Date 03/05/2024; 2331287, Exp. Date 03/14/2024.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Superpotent