Drug recall
Fluoracaine, Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution USP, Sterile, Rx Only…
FDA recall event 25285 · Class II · Akorn, Inc.
Key facts
| Event ID | 25285 |
|---|---|
| Recall numbers | D-155-3, D-156-3 |
| Recalling firm | Akorn, Inc. |
| Product type | Drugs |
| Products | Fluoracaine, Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution USP, Sterile, Rx Only, Active : Fluorescein Sodium 0.25%, Proparacaine Hydrochloride 0.5% ; 5 mL glass screw cap vial…, Fluress, Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP; Sterile , Active :Fluorescein Sodium 0.25%, Benoxinate Hydrochloride 0.4%, 5 mL glass screw cap vial with black… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Container/closure integrity problem: leaking containers, Container/closure integrity problems: leaking containers |
| Initiation date | Jan 14, 2003 |
| City | Decatur |
| Country | United States |
| FEI number | 1450114 |
At a glance
- 1–9 Products in this recall
- 10–99 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