Drug recall
Cornea
FDA recall event 90007 · Class II · CorneaGen
Key facts
| Event ID | 90007 |
|---|---|
| Recall numbers | B-0376-2022, B-0377-2022 |
| Recalling firm | CorneaGen |
| Product type | Biologics |
| Products | Cornea, Sclera |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Tissues, recovered from donors in which donor suitability was not adequately determined, were distributed. Donors tested reactive for antibody to Hepatitis B core antigen. |
| Initiation date | Jan 5, 2022 |
| Report date | Jun 1, 2022 |
| Termination date | May 24, 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: