USPlabs, LLC

Recall #F-1374-2014 · Initiated 2013-11-09

Plain-language summary

by FoodRecallsDB.info

What happened

USPlabs is recalling a dietary supplement powder (OxyELITE Pro Super Thermo POWDER Plus) because it contains an ingredient called Aegeline that has been linked to serious liver damage and liver failure in some people who used it. The FDA asked the company to recall this product due to these safety concerns.

Who is at risk

Anyone who has used this product is potentially at risk, as serious liver damage can occur in users.

What to do

If you have this product, stop using it immediately. Contact your doctor if you have experienced any symptoms like yellowing of the skin or eyes, unusual fatigue, abdominal pain, or dark urine. You can return the product to where you purchased it or contact USPlabs for a refund.

Product

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

10,306 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 #094922447500

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Press Release

Terminated

2015-10-13