Drug recall
Source Plasma
FDA recall event 35114 · Class II · DCI Biologicals Nacogdoches, LLC
Key facts
| Event ID | 35114 |
|---|---|
| Recall numbers | B-1447-6 |
| Recalling firm | DCI Biologicals Nacogdoches, LLC |
| Product type | Biologics |
| Products | Source Plasma |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood product, which tested negative for hepatitis B surface antigen (HBsAg), but was collected from a donor who subsequently tested positive for HBsAg, was not properly quarantined and was… |
| Initiation date | Feb 13, 2003 |
| Termination date | Aug 11, 2006 |
| City | Nacogdoches |
| Country | United States |
| FEI number | 3003190471 |
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