Terminated Class I

USPlabs, LLC

Recall F-1371-2014 · Dallas, TX

Product

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.

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

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.

Quantity affected

1,065,783 units

Recall type

Voluntary: Firm initiated

Lot / code info

3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869

Timeline

9 Nov 2013 initiated 15 Jan 2014 classified 22 Jan 2014 reported 13 Oct 2015 terminated

Sourced directly from the FDA’s openFDA enforcement database. This information is for educational purposes only and does not constitute health or legal advice. FoodRecallFinder.com is not affiliated with or endorsed by the U.S. Food and Drug Administration.