Drug recall
Fibrin Sealant
FDA recall event 83696 · Class III · Omrix Biopharmaceuticals, Ltd.
Key facts
| Event ID | 83696 |
|---|---|
| Recall numbers | B-0869-2019 |
| Recalling firm | Omrix Biopharmaceuticals, Ltd. |
| Product type | Biologics |
| Products | Fibrin Sealant |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | EVICEL Fibrin Sealant 5mL Sample, (Not for Sale) and not meeting product specifications, was distributed. |
| Initiation date | Jul 8, 2019 |
| Report date | Sep 11, 2019 |
| Termination date | Sep 4, 2019 |
| City | Ramat Gan |
| Country | Israel |
| FEI number | 3003183625 |
At a glance
- 1–9 Products in this recall
- 1–9 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: