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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64741
Product Type Biologics
Status Terminated
Recalling Firm Ortho Clinical Diagnostics Inc
City Raritan
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Multiple U.S. States

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Rho(D) Immune Globulin (Human) RVP166A1, RVP167A1, RVP164A1 Class III Rh Immune Globulin, lacking assurance of proper temperature maintenance during transit, was distributed. 3 B-1431-13