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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Event Detail

Event ID 59516
Product Type Biologics
Status Terminated
Recalling Firm Octapharma Plasma, Inc.
City Fort Worth
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-06
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern CA, Switzerland

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 5200026069, 5200026406, 5200027561, 5200027908, 5200028505, 5200028965, 5200029669, 5200030096, 5200030750, 5200034043, 5200034835, 5200035230, 5200035752, 5200036034, 5200036604, 5200036928, 5200037499, 5200037813, 5200038699, 5200039079, 5200039639 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 21 units B-1064-13
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