Food 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.
F-1371-2014
Product summary
- Firm
- USPlabs, LLC
- Event
- Event 66813
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,065,783 units
- Official record key
food-enforcement:F-1371-2014
Official wording
Reason: 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.
Code information: 3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
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.
Derived failure modes
-
Unknown
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.