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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 59515
Product Type Biologics
Status Terminated
Recalling Firm Octapharma Plasma, Inc.
City Charlotte
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-01
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern CA, Austria

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 4270048655, 4270047980, 4270047086, 4270046540, 4270045902, 4270044950, 4270044614, 4270044149, 4270043875, 4270042392, 4270042054, 4270041511, 4270040729, 4270040476, 4270039910, 4270039604, 4270038051, 4270037444, 4270034510, 4270034756, 4270035549, 4270036211, 4270036424, 4270033296, 4270033874, 4270037101, 4270032362, 4270025109, 4270031713, 4270032690, 4270029598, 4270029850, 4270030688, 4270030976, 4270027551, 4270029059 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 36 units B-2195-12
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