USPlabs, LLC

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

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