Drug recall
Quixin (levofloxacin) 0.5%, Sterile Topical Ophthalmic solution, 5 mL, Bottle-Dropper, Rx Only, Manufactured…
FDA recall event 55433 · Class III · Santen Inc
Key facts
| Event ID | 55433 |
|---|---|
| Recall numbers | D-610-2010 |
| Recalling firm | Santen Inc |
| Product type | Drugs |
| Products | Quixin (levofloxacin) 0.5%, Sterile Topical Ophthalmic solution, 5 mL, Bottle-Dropper, Rx Only, Manufactured by: Santen Oy, P.O. Box 33, FIN-33721 Tampere, Finland; Marketed by: VISTAKON… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: out of specification levofloxacin-N-oxide (NOXO) |
| Initiation date | Apr 14, 2010 |
| Termination date | Dec 9, 2010 |
| City | Napa |
| State | CA |
| Country | United States |
| FEI number | 1000606419 |
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