USPlabs, LLC

Recall #F-1375-2014 · Initiated 2013-11-09

Plain-language summary

by FoodRecallsDB.info

What happened

USPlabs recalled their OxyELITE Pro Super Thermo Powder Plus (green apple flavor) because it contains an ingredient called Aegeline that has been linked to serious liver damage and liver failure in some people. The FDA asked the company to remove this product from the market.

Who is at risk

Anyone who has used or currently uses this dietary supplement is potentially at risk, regardless of age or health status.

What to do

Stop using this product immediately if you have it. If you've used this supplement and experience symptoms like yellowing of skin or eyes, dark urine, severe fatigue, or abdominal pain, contact a doctor right away and mention the product name.

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