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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Detail

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

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