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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description 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.
Recall Number D-837-2013
Classification Class I
Code Info Lot #: 99515, Exp 09/2016
Product Distributed Qty 586 bottles
Reason For Recall Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.

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.