Drug recall
Monoclate-P Antihemophilic Factor (Human), 1000 units, Factor VIII:C Pasteurized Monoclonal Antibody Purified…
FDA recall event 49364 · Class III · CSL Behring LLC
Key facts
| Event ID | 49364 |
|---|---|
| Recall numbers | B-1892-08 |
| Recalling firm | CSL Behring LLC |
| Product type | Biologics |
| Products | Monoclate-P Antihemophilic Factor (Human), 1000 units, Factor VIII:C Pasteurized Monoclonal Antibody Purified; an Rx product, for intravenous administration only, store at 2-8 degrees C; Manufactured… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Monoclate-P lots, which did not meet the potency assay requirements for stability testing at 3 months at 5 degrees C storage, were distributed. |
| Initiation date | Aug 18, 2008 |
| Termination date | Nov 3, 2009 |
| City | Bradley |
| State | IL |
| Country | United States |
| FEI number | 1410248 |
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