Drug product
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
D-0278-2024
Product summary
- Event
- Event 93710
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 13,920 IV bags
- Official record key
drug-enforcement:D-0278-2024
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 #: 2330988, Exp. Date 01/31/2024; 2331058, Exp. Date 02/18/2024; 2331150, Exp. Date 03/10/2024; 2331231, Exp. Date 03/24/2024; 2331289, Exp. Date 03/30/2024.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Superpotent