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U.S. Department of Health and Human Services

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
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