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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 64182
Product Type Drugs
Status Ongoing
Recalling Firm Reumofan Plus USA
City Springfield
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide through internet sales.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico. Lot #: 99515, Exp 09/2016 Class I Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol. 586 bottles D-837-2013
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