Drug recall
Source Plasma
FDA recall event 29435 · Class II · Biomat USA, Inc
Key facts
| Event ID | 29435 |
|---|---|
| Recall numbers | B-1806-4 |
| Recalling firm | Biomat USA, Inc |
| Product type | Biologics |
| Products | Source Plasma |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Source Plasma, collected from a donor who tested positive for hepatitis B surface antigen (HBsAg) by PCR testing, was distributed. |
| Initiation date | Aug 8, 2002 |
| Termination date | Sep 1, 2004 |
| City | Dallas |
| Country | United States |
| FEI number | 1626549 |
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