Drug recall
Pooled Cryoprecipitated AHF
FDA recall event 79187 · Class II · Carter BloodCare - Tyler
Key facts
| Event ID | 79187 |
|---|---|
| Recall numbers | B-0381-2018 |
| Recalling firm | Carter BloodCare - Tyler |
| Product type | Biologics |
| Products | Pooled Cryoprecipitated AHF |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, in which quality control for Factor VIII testing did not meet specifications, were distributed. |
| Initiation date | Jan 23, 2018 |
| Report date | Mar 14, 2018 |
| Termination date | Mar 2, 2018 |
| City | Tyler |
| State | TX |
| Country | United States |
| FEI number | 1672331 |
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: