Drug recall
Pooled Cryoprecipitated AHF
FDA recall event 87599 · Class II · Gulf Coast Regional Blood Center
Key facts
| Event ID | 87599 |
|---|---|
| Recall numbers | B-0379-2021, B-0380-2021 |
| Recalling firm | Gulf Coast Regional Blood Center |
| Product type | Biologics |
| Products | Pooled Cryoprecipitated AHF, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood products, collected from a donor who previously tested positive for the antibody to hepatitis B core antigen (anti-HBc) on two separate occasions, were distributed. |
| Initiation date | Feb 23, 2021 |
| Report date | Apr 21, 2021 |
| Termination date | Apr 10, 2021 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3002133806 |
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 · Source date: