Drug recall
Prothrombin Complex Concentrate (Human)
FDA recall event 82976 · Class III · CSL Behring GmbH
Key facts
| Event ID | 82976 |
|---|---|
| Recall numbers | B-0653-2019 |
| Recalling firm | CSL Behring GmbH |
| Product type | Biologics |
| Products | Prothrombin Complex Concentrate (Human) |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Misbranded Kcentra lot was distributed. |
| Initiation date | Apr 5, 2019 |
| Report date | Jun 12, 2019 |
| Termination date | Jun 5, 2019 |
| City | Marburg |
| Country | Germany |
| FEI number | 3003098680 |
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: