Denver Solutions, LLC DBA Leiters Health: Drug Recall
Recall #D-0278-2024 · 12/28/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0278-2024
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Status
- Ongoing
- Date Initiated
- 12/28/2023
- Location
- Englewood, CO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,920 IV bags
Reason for Recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
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.
Distribution Pattern
Nationwide within the United States
Other Recalls by Denver Solutions, LLC DBA Leiters Health
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
- Class II: Risk 03/31/2025
View all recalls by Denver Solutions, LLC DBA Leiters Health →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.