Drug recall
Apheresis Platelets, Leukocytes Reduced
FDA recall event 95107 · Class III · Versiti Indiana Inc
Key facts
| Event ID | 95107 |
|---|---|
| Recall numbers | B-0466-2024, B-0467-2024, B-0468-2024 |
| Recalling firm | Versiti Indiana Inc |
| Product type | Biologics |
| Products | Apheresis Platelets, Leukocytes Reduced, Apheresis Platelets, Leukocytes Reduced, Irradiated, Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Blood Products, which were exposed to unacceptable storage temperatures, were distributed. |
| Initiation date | May 21, 2024 |
| Report date | Aug 28, 2024 |
| Termination date | Aug 19, 2024 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1873403 |
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: