USPlabs, LLC

Recall #F-1372-2014 · Initiated 2013-11-09

Product

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

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

645,826 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

Fruit Prunch 0.15 oz, UPC #094922417237 and UPC #094922447517; Fruit Punch 4.6 oz, UPC #094922426369; Fruit Punch 5 oz, UPC #094922447487

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Press Release

Terminated

2015-10-13