Drug recall
Valstar (Valrubicin) Sterile Solution for Intravesical Instillation 200mg/5mL (40mg/mL); Rx Only; For…
FDA recall event 58448 · Class II · Endo Pharmaceuticals, Inc.
Key facts
| Event ID | 58448 |
|---|---|
| Recall numbers | D-725-2011 |
| Recalling firm | Endo Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Valstar (Valrubicin) Sterile Solution for Intravesical Instillation 200mg/5mL (40mg/mL); Rx Only; For Inravesical Use Only, NOT for IM or IV use; Manufactured for: Endo Pharmaceuticals Solutions Inc… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Package Insert: One section incorrectly states, "Sterile Solution for Intravenous Instillation." The correct wording should be, "Sterile Solution for Intravesical… |
| Initiation date | Apr 7, 2011 |
| Termination date | May 24, 2012 |
| City | Chadds Ford |
| State | PA |
| Country | United States |
| FEI number | 3001578003 |
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