Drug recall
Source Leukocytes
FDA recall event 74960 · Class III · Gulf Coast Regional Blood Center
Key facts
| Event ID | 74960 |
|---|---|
| Recall numbers | B-0764-16 |
| Recalling firm | Gulf Coast Regional Blood Center |
| Product type | Biologics |
| Products | Source Leukocytes |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. |
| Initiation date | Jul 13, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | Sep 12, 2016 |
| 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: