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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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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