Drug recall
Treanda (bendamustine HCL) for injection, 25mg/vial, Sterile-Single Use Vial, Rx Only, Mfr for Cephalon Inc…
FDA recall event 60428 · Class I · Cephalon, Inc.
Key facts
| Event ID | 60428 |
|---|---|
| Recall numbers | D-1254-2012 |
| Recalling firm | Cephalon, Inc. |
| Product type | Drugs |
| Products | Treanda (bendamustine HCL) for injection, 25mg/vial, Sterile-Single Use Vial, Rx Only, Mfr for Cephalon Inc Frazer, PA 19355, NDC 63459-0390-08 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter; Glass fragments have been reported in a single vial. |
| Initiation date | Nov 18, 2011 |
| Termination date | Dec 4, 2014 |
| 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