Drug recall
Source Plasma
FDA recall event 78497 · Class II · KEDPlasma USA, LLC
Key facts
| Event ID | 78497 |
|---|---|
| Recall numbers | B-0150-2018 |
| Recalling firm | KEDPlasma USA, LLC |
| Product type | Biologics |
| Products | Source Plasma |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Plasma products, which where not quarantined after receiving information that warranted donor deferral, were distributed. |
| Initiation date | Oct 10, 2017 |
| Report date | Dec 20, 2017 |
| Termination date | Dec 12, 2017 |
| City | Mobile |
| State | AL |
| Country | United States |
| FEI number | 3006210763 |
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: