Drug recall
Rabies Immune Globulin (Human)
FDA recall event 75522 · Class III · Sanofi Pasteur S.A.
Key facts
| Event ID | 75522 |
|---|---|
| Recall numbers | B-0120-2017 |
| Recalling firm | Sanofi Pasteur S.A. |
| Product type | Biologics |
| Products | Rabies Immune Globulin (Human) |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sanofi Pasteur's IMOGAM RABIES-HT (Rabies Immune Globulin [Human] USP, Heat Treated), with an antibody content that has declined below the stability specification limit, was distributed. |
| Initiation date | Apr 26, 2016 |
| Report date | Nov 23, 2016 |
| Termination date | Nov 14, 2016 |
| City | Marcy l'Etoile |
| Country | France |
| FEI number | 3002972083 |
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: