Drug recall
Fresh Frozen Plasma
FDA recall event 35971 · Class II · Gulf Coast Regional Blood Center
Key facts
| Event ID | 35971 |
|---|---|
| Recall numbers | B-1751-6 |
| Recalling firm | Gulf Coast Regional Blood Center |
| Product type | Biologics |
| Products | Fresh Frozen Plasma |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. |
| Initiation date | Sep 16, 2005 |
| Termination date | Sep 5, 2006 |
| City | Houston |
| Country | United States |
| FEI number | 3002133806 |
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