Drug recall
Corneal tissue for transplant.
FDA recall event 45471 · Class II · Georgia Eye Bank
Key facts
| Event ID | 45471 |
|---|---|
| Recall numbers | B-0844-08 |
| Recalling firm | Georgia Eye Bank |
| Product type | Biologics |
| Products | Corneal tissue for transplant. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissues from donors, tested using diagnostic test kits rather than FDA licensed or cleared screening tests for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen… |
| Initiation date | Oct 15, 2007 |
| Termination date | Mar 14, 2008 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 3001237886 |
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