Drug recall
Source Plasma
FDA recall event 34479 · Class II · Talecris Biotherapeutics, Inc.
Key facts
| Event ID | 34479 |
|---|---|
| Recall numbers | B-1364-6 |
| Recalling firm | Talecris Biotherapeutics, Inc. |
| Product type | Biologics |
| Products | Source Plasma |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, which were incorrectly tested for hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed. |
| Initiation date | Jul 30, 1998 |
| Termination date | Jun 30, 2006 |
| City | Raleigh |
| Country | United States |
| FEI number | 2077831 |
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