FDAFDA · Food and drugs·Recall number D-0277-2024
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.
Published February 7, 2024 · Recall initiated: December 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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