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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 38917
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Farmington
State CT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-06-30
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Connecticut

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Helixate FS Antihemophilic Factor (Recombinant), Formulated with Sucrose Lot Nos: 27N1162, 27N10V1, 27N11J1, 27N1501, 27N1511 Class III Antihemophilic Factor (Recombinant), lacking assurance of proper temperature maintenance during storage, was distributed. 5 B-0193-13
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