Home / USPlabs, LLC / F-1375-2014
Class I
USPlabs, LLC
Recall #F-1375-2014 · Initiated 2013-11-09
Product
USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GREEN APPLE Manufactured for USPlabs, LLC (Dallas, TX 75220)
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.
Quantity affected
21,325 units
Distribution
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.
Lot / code info
UPC #094922426499
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Press Release
Terminated
2015-10-13
Recalling firm
USPlabs, LLC
10761 King William Dr
Dallas, TX 75220-2445
United States
Recall classification
Most serious. Reasonable probability that the product will cause serious health consequences or death.
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