Drug product
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
D-0277-2024
Product summary
- Event
- Event 93710
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 8,976 IV bags
- Official record key
drug-enforcement:D-0277-2024
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 #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Superpotent