Drug recall
Red Blood Cells (Apheresis) Leukocytes Reduced
FDA recall event 68254 · Class III · Gulf Coast Regional Blood Center
Key facts
| Event ID | 68254 |
|---|---|
| Recall numbers | B-0727-14, B-0728-14 |
| Recalling firm | Gulf Coast Regional Blood Center |
| Product type | Biologics |
| Products | Red Blood Cells (Apheresis) Leukocytes Reduced, Red Blood Cells Leukocytes Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor with a history of polycythemia, were distributed. |
| Initiation date | Apr 1, 2014 |
| Report date | Jun 25, 2014 |
| Termination date | Jun 13, 2014 |
| City | Houston |
| State | TX |
| 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 · Source date: