Drug recall
Ifosfamide Injection, 1 g/20 mL (50 mg/mL), 20 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC…
FDA recall event 59395 · Class II · App Pharmaceuticals Llc
Key facts
| Event ID | 59395 |
|---|---|
| Recall numbers | D-770-2011, D-771-2011 |
| Recalling firm | App Pharmaceuticals Llc |
| Product type | Drugs |
| Products | Ifosfamide Injection, 1 g/20 mL (50 mg/mL), 20 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-174-20, UPC 3 63323-174-20 0, Ifosfamide Injection, 3 g/60 mL (50 mg/mL), 60 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173; NDC 63323-174-60; UPC 3 63323-174-60 6 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: Out-of-specification results for Any Other Individual Impurity were obtained during stability testing at the 12-month test station. |
| Initiation date | Jul 15, 2011 |
| Termination date | Aug 28, 2012 |
| City | Schaumburg |
| State | IL |
| Country | United States |
| FEI number | 3002733956 |
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