F-1374-2014 Class I Terminated

Recalled by USPlabs, LLC — Dallas, TX

Recall Details

Product Type
Food
Report Date
January 22, 2014
Initiation Date
November 9, 2013
Termination Date
October 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,306 units

Product Description

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GRAPE BUBBLEGUM 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.

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.

Code Information

UPC #094922447500