Drug recall
Human Cornea Tissue
FDA recall event 28105 · Class I · Rocky Mountain Lions Eye Bank
Key facts
| Event ID | 28105 |
|---|---|
| Recall numbers | B-0772-4 |
| Recalling firm | Rocky Mountain Lions Eye Bank |
| Product type | Biologics |
| Products | Human Cornea Tissue |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissues for transplantation, procured from a donor who tested negative for antibody to hepatitis C virus (anti-HCV), but was subsequently found to have tested positive for the hepatitis C virus… |
| Initiation date | May 16, 2003 |
| Termination date | Aug 17, 2004 |
| City | Aurora |
| Country | United States |
| FEI number | 1000517466 |
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