Enforcement Report - Week of January 30, 2013
-
Back to Previous Page
Product Detail
| Product Description | Sipuleucel-T |
|---|---|
| Recall Number | B-0392-13 |
| Classification | Class III |
| Code Info | 3044411 |
| Product Distributed Qty | One unit |
| Reason For Recall | Provenge (sipuleucel-T), with an out-of-specification (OOS) assay result, was distributed. |
Event Detail
| Event Id | 61340 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Dendreon Corporation |
| City | Union City |
| State | GA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-12-12 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | TX |
-
