USPlabs, LLC

Recall #F-1376-2014 · Initiated 2013-11-09

Plain-language summary

by FoodRecallsDB.info

What happened

USPlabs is recalling a dietary supplement powder called OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System (Raspberry Lemonade flavor) because it contains an ingredient called Aegeline that has been linked to serious liver damage and liver failure in some people who used it.

Who is at risk

Anyone who purchased and used this specific product should be concerned, as the liver damage has occurred in multiple people.

What to do

If you have this product, stop using it immediately. Contact USPlabs or your healthcare provider if you have experienced symptoms like yellowing of skin or eyes, unusual fatigue, dark urine, or abdominal pain. You can also report your experience to the FDA.

Product

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

10,278 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 #094922447494

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Press Release

Terminated

2015-10-13