Drug product
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
D-0281-2024
Product summary
- Event
- Event 93710
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 10,152 IV bags
- Official record key
drug-enforcement:D-0281-2024
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 #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Superpotent