USPlabs, LLC

Recall #F-1371-2014 · Initiated 2013-11-09

Plain-language summary

by FoodRecallsDB.info

What happened

USPlabs is recalling its OxyELITE Pro Ultra-Intense Thermo Advanced Formula dietary supplement because it contains an ingredient called Aegeline that has been linked to serious liver damage and liver failure in some people. The FDA determined this is a serious enough issue to require a full recall.

Who is at risk

Anyone who has used this supplement is potentially at risk, especially if they have experienced any symptoms of liver problems.

What to do

Stop using this product immediately if you have it. If you have taken this supplement and develop symptoms like yellowing of skin or eyes, dark urine, unusual fatigue, or abdominal pain, contact your doctor right away and mention the supplement use. You can also report any health problems to the FDA at SafetyReporting.HHS.gov.

Product

USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.

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

1,065,783 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

3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Press Release

Terminated

2015-10-13