Denver Solutions, LLC DBA Leiters Health: Drug Recall
Recall #D-0282-2024 · 12/28/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0282-2024
- 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
- 7,548 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
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
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.