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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
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