F-1370-2014 Class I Terminated
Recall Details
- Product Type
- Food
- Report Date
- January 22, 2014
- Initiation Date
- November 9, 2013
- Termination Date
- October 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,166,328 units
Product Description
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.
Distribution Pattern
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.
Code Information
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