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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 Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz
Recall Number F-1372-2014
Classification Class I
Code Info Fruit Prunch 0.15 oz, UPC #094922417237 and UPC #094922447517; Fruit Punch 4.6 oz, UPC #094922426369; Fruit Punch 5 oz, UPC #094922447487
Product Distributed Qty 645,826 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.