Drug recall
Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound…
FDA recall event 63282 · Class III · Ethicon, Inc.
Key facts
| Event ID | 63282 |
|---|---|
| Recall numbers | B-1048-13, B-1049-13 |
| Recalling firm | Ethicon, Inc. |
| Product type | Biologics |
| Products | Fibrin Sealant (Human) Evicel Rx Only Sterile Disposable Single Use Distributed by: Johnson and Johnson Wound Management A division of Ethicon Inc. Johnson & Johnson Wound Management A division of…, Thrombin, Topical (Human) Evithrom Rx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed. |
| Initiation date | Sep 27, 2012 |
| Report date | Feb 27, 2013 |
| Termination date | Nov 18, 2015 |
| City | Somerville |
| State | NJ |
| Country | United States |
| FEI number | 2210968 |
At a glance
- 1–9 Products in this recall
- None 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: