Drug recall
Recovered Plasma
FDA recall event 28585 · Class III · Central Texas Regional Blood & Tissue Center
Key facts
| Event ID | 28585 |
|---|---|
| Recall numbers | B-1127-4, B-1128-4 |
| Recalling firm | Central Texas Regional Blood & Tissue Center |
| Product type | Biologics |
| Products | Recovered Plasma, Red Blood Cells, Leukocytes Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, that tested negative for antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive to anti-HCV, were distributed. |
| Initiation date | Sep 9, 2003 |
| Termination date | Apr 22, 2004 |
| City | Austin |
| Country | United States |
| FEI number | 1671794 |
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