FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV...
FDA Recall #D-0278-2024 — Class I — December 28, 2023
Product Description
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.
Reason for Recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recalling Firm
Denver Solutions, LLC DBA Leiters Health — Englewood, CO
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
13,920 IV bags
Distribution
Nationwide within the United States
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated