Drug recall
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx…
FDA recall event 67689 · Class II · Sagent Pharmaceuticals Inc
Key facts
| Event ID | 67689 |
|---|---|
| Recall numbers | D-1615-2014 |
| Recalling firm | Sagent Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility; leaking of premix bags |
| Initiation date | Mar 4, 2014 |
| Report date | Oct 8, 2014 |
| Termination date | Jul 7, 2016 |
| City | Schaumburg |
| State | IL |
| Country | United States |
| FEI number | 3006167046 |
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: