USPlabs, LLC

Recall #F-1373-2014 · Initiated 2013-11-09

Plain-language summary

by FoodRecallsDB.info

What happened

USPlabs is recalling OxyELITE Pro Super Thermo POWDER Plus (Blue Raspberry flavor) dietary supplements because they contain an ingredient called Aegeline that has been linked to serious liver damage and acute liver failure in some users. The FDA required this voluntary recall after receiving reports of these serious health problems.

Who is at risk

Anyone who has used this specific product should be concerned, as the liver damage can be serious.

What to do

Stop using this product immediately if you have it. Contact your doctor right away if you've been using it and experience symptoms like yellowing of the skin or eyes, dark urine, unusual fatigue, or abdominal pain. You can return the product to where you purchased it or dispose of it safely.

Product

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

71,499 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 #094922426376

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Press Release

Terminated

2015-10-13