Denver Solutions, LLC DBA Leiters Health: Drug Recall
Recall #D-0361-2024 · 02/20/2024
Class II: Risk
Recall Details
- Recall Number
- D-0361-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Denver Solutions, LLC DBA Leiters Health
- Status
- Ongoing
- Date Initiated
- 02/20/2024
- Location
- Englewood, CO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,090 vials
Reason for Recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Product Description
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
Distribution Pattern
Nationwide in the USA
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.