Drug recall
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters…
FDA recall event 89136 · Class II · Denver Solutions, LLC DBA Leiters Health
Key facts
| Event ID | 89136 |
|---|---|
| Recall numbers | D-0288-2022 |
| Recalling firm | Denver Solutions, LLC DBA Leiters Health |
| Product type | Drugs |
| Products | Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL |
| Initiation date | Nov 29, 2021 |
| Report date | Dec 29, 2021 |
| Termination date | Jul 12, 2022 |
| City | Englewood |
| State | CO |
| Country | United States |
| FEI number | 3013438582 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: