Drug recall
Recovered Plasma, for manufacturing injectable products
FDA recall event 31821 · Class II, Class III · Oklahoma Blood Institute - Sylvan N Goldman Center
Key facts
| Event ID | 31821 |
|---|---|
| Recall numbers | B-1272-5, B-1273-5, B-1274-5 |
| Recalling firm | Oklahoma Blood Institute - Sylvan N Goldman Center |
| Product type | Biologics |
| Products | Recovered Plasma, for manufacturing injectable products, Recovered Plasma for manufacturing non-injectable products, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed. |
| Initiation date | Aug 21, 2003 |
| Termination date | Jun 7, 2005 |
| City | Oklahoma City |
| Country | United States |
| FEI number | 1626009 |
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