Drug recall
Recovered Plasma
FDA recall event 27526 · Class II · ARC / New England Region
Key facts
| Event ID | 27526 |
|---|---|
| Recall numbers | B-0989-4 |
| Recalling firm | ARC / New England Region |
| Product type | Biologics |
| Products | Recovered Plasma |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, that tested negative for hepatitis, but was collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, was distributed. |
| Initiation date | Jul 17, 2003 |
| Termination date | Apr 13, 2004 |
| City | Dedham |
| Country | United States |
| FEI number | 1270026 |
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