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U.S. Department of Health and Human Services

Enforcement Report - Week of April 30, 2014

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Product Detail

Product Description RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Recall Number D-1248-2014
Classification Class I
Code Info Lots QL110408B046, QL110714A102 Exp. 11/13
Product Distributed Qty 50,300 capsules
Reason For Recall Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

Event Detail

Event Id 66878
Product Type Drugs
Status Ongoing
Recalling Firm Fossil Fuel Products, LLC
City Dallas
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-18
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide.