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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Recall Number D-265-2013
Classification Class I
Code Info Lot number 008A, expiration date Dec 2014, UPC code 830733002016
Product Distributed Qty 30,000 capsules
Reason For Recall Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction

Event Detail

Event Id 62836
Product Type Drugs
Status Completed
Recalling Firm Body Basics Inc
City Canoga Park
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-12-19
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide
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