Drug recall
Sclera
FDA recall event 90008 · Class I · CorneaGen
Key facts
| Event ID | 90008 |
|---|---|
| Recall numbers | B-0374-2022 |
| Recalling firm | CorneaGen |
| Product type | Biologics |
| Products | Sclera |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Sclera, recovered from a donor in which donor suitability was not adequately determined, was distributed. |
| Initiation date | Jan 5, 2022 |
| Report date | May 25, 2022 |
| Termination date | May 19, 2022 |
| City | South San Francisco |
| State | CA |
| Country | United States |
| FEI number | 3009122697 |
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: