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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.
Recall Number F-1371-2014
Classification Class I
Code Info 3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
Product Distributed Qty 1,065,783 units
Reason For Recall USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

Event Detail

Event Id 66813
Product Type Food
Status Ongoing
Recalling Firm USPlabs, LLC
City Dallas
State TX
Country US
Voluntary / Mandated
Recall Initiation Date 2013-11-09
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.