Drug recall
Genzyme Thymoglobulin¿ [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC…
FDA recall event 62670 · Class II · Genzyme Corporation
Key facts
| Event ID | 62670 |
|---|---|
| Recall numbers | B-0964-13 |
| Recalling firm | Genzyme Corporation |
| Product type | Biologics |
| Products | Genzyme Thymoglobulin¿ [Anti-thymocyte Globulin (Rabbit)], 25 mg, for intravenous use only, Rx. NDC 58468-0080-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Anti-Thymocyte Globulin (Rabbit) 25 mg, with an OOS assay result on the molecular size distribution stability test, was distributed. |
| Initiation date | Jul 26, 2012 |
| Report date | Feb 13, 2013 |
| Termination date | Jul 22, 2013 |
| City | Framingham |
| State | MA |
| Country | United States |
| FEI number | 1220423 |
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: