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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Event Detail

Event ID 63017
Product Type Drugs
Status Ongoing
Recalling Firm Samantha Lynn, Inc
City Norwalk
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-27
Initial Firm Notification of
Consignee or Public
Press Release
Distribution Pattern Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) all lots within expiry through 2016 Class I Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug. 25,888 Boxes D-063-2013
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