USPlabs, LLC

Recall #F-1372-2014 · Initiated 2013-11-09

Plain-language summary

by FoodRecallsDB.info

What happened

USPlabs is recalling OxyELITE Pro Super Thermo POWDER Plus in Fruit Punch flavor because it contains an ingredient called Aegeline that has been linked to serious liver damage and acute liver failure in some users. The FDA determined this risk is serious enough to require the recall.

Who is at risk

Anyone who has used this product is at potential risk, regardless of age or health status.

What to do

Stop using this product immediately if you have it. Contact a poison control center or seek medical attention right away if you experience symptoms like yellowing of skin or eyes, dark urine, abdominal pain, or unexplained fatigue. Check with the retailer where you purchased it about returns or refunds.

Product

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz

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

645,826 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

Fruit Prunch 0.15 oz, UPC #094922417237 and UPC #094922447517; Fruit Punch 4.6 oz, UPC #094922426369; Fruit Punch 5 oz, UPC #094922447487

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Press Release

Terminated

2015-10-13