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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

Product Description Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Recall Number D-063-2013
Classification Class I
Code Info all lots within expiry through 2016
Product Distributed Qty 25,888 Boxes
Reason For Recall 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.

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
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