Enforcement Report - Week of January 30, 2013
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Sipuleucel-T | 3044411 | Class III | Provenge (sipuleucel-T), with an out-of-specification (OOS) assay result, was distributed. | One unit | B-0392-13 |
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