Drug recall
Human Cornea for Transplantation Tissue (1 tissue) 06-0137-200
FDA recall event 36372 · Class II · East Tennessee Lions Eye Bank
Key facts
| Event ID | 36372 |
|---|---|
| Recall numbers | B-0211-7 |
| Recalling firm | East Tennessee Lions Eye Bank |
| Product type | Biologics |
| Products | Human Cornea for Transplantation Tissue (1 tissue) 06-0137-200 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue for transplantation, that tested negative for hepatitis prior to distribution, was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBcore)… |
| Initiation date | Jul 28, 2006 |
| Termination date | Nov 14, 2006 |
| City | Knoxville |
| Country | United States |
| FEI number | 3002689373 |
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