Drug recall
Source Plasma
FDA recall event 84393 · Class III · CSL Plasma, Inc
Key facts
| Event ID | 84393 |
|---|---|
| Recall numbers | B-0211-2020 |
| Recalling firm | CSL Plasma, Inc |
| Product type | Biologics |
| Products | Source Plasma |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. |
| Initiation date | Sep 13, 2019 |
| Report date | Jan 8, 2020 |
| Termination date | Dec 31, 2019 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 3013407268 |
At a glance
- 1–9 Products in this recall
- 1–9 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: