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U.S. Department of Health and Human Services

Enforcement Report - Week of April 30, 2014

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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.

Product Detail

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