USPlabs, LLC

Recall #F-1370-2014 · Initiated 2013-11-09

Plain-language summary

by FoodRecallsDB.info

What happened

USPlabs is recalling their OxyELITE Pro Super Thermo dietary supplement because it contains an ingredient called Aegeline that has been linked to serious liver damage and acute liver failure in some users. The FDA classified this as a serious safety concern.

Who is at risk

Anyone who has used this product is potentially at risk, particularly those who may have taken it regularly or in larger amounts.

What to do

Stop using this product immediately if you have it. Contact your doctor right away if you experience symptoms like yellowing of skin or eyes, unusual fatigue, abdominal pain, or dark urine, as these may indicate liver problems. You can also report your experience to the FDA's MedWatch program.

Product

USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.

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

2,166,328 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

2 count capsules, UPC # 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 094922447852

Voluntary / mandated

Voluntary: Firm initiated

Initial notification

Press Release

Terminated

2015-10-13