Class I
Ongoing
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.
This recall is currently active, issued February 7, 2024. It was issued by Denver Solutions, Llc Dba Leiters Health.
- Recall Initiated
- December 28, 2023
- Posted
- February 7, 2024
- Recall Number
- D-0277-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,976 IV bags
- Firm Location
- Englewood, CO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.
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