Drug recall
Immune Globulin Intravenous (Human)
FDA recall event 70420 · Class II · Biotest Pharmaceuticals Corp.
Key facts
| Event ID | 70420 |
|---|---|
| Recall numbers | B-0445-15 |
| Recalling firm | Biotest Pharmaceuticals Corp. |
| Product type | Biologics |
| Products | Immune Globulin Intravenous (Human) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Various lots of BIVIGAM (Immune Globulin Intravenous (Human), 10% Liquid), 100 mL vial, with a potential for a very small percentage of the vials to exhibit a vial integrity defect, were distributed. |
| Initiation date | Feb 20, 2014 |
| Report date | Mar 18, 2015 |
| Termination date | Mar 9, 2015 |
| City | Boca Raton |
| State | FL |
| Country | United States |
| FEI number | 1000525461 |
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: