Drug recall
Treanda (bendamustine HCl) for Injection, 25 mg/vial, lyophilized powder in a Single Use Vial, Rx Only…
FDA recall event 61511 · Class III · Cephalon, Inc.
Key facts
| Event ID | 61511 |
|---|---|
| Recall numbers | D-1308-2012 |
| Recalling firm | Cephalon, Inc. |
| Product type | Drugs |
| Products | Treanda (bendamustine HCl) for Injection, 25 mg/vial, lyophilized powder in a Single Use Vial, Rx Only, Manufactured for: Cephalon Inc., Frazer, PA 19355, NDC 63459-390-08, UPC 3 63459 390 08 6. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Impurities/Degradation Products: Product is being recalled due to an Out of Specification result for an impurity in Lot Number TB30411 of Treanda(R) 25 mg (8 mL vial). |
| Initiation date | Mar 15, 2012 |
| Termination date | Apr 2, 2013 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 1000307054 |
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