FDA recalls · F-1371-2014
USPlabs, LLC recall
- FoodUSPlabs 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.
- ReasonUSPlabs, 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.
- ClassClass I: most serious: the food could cause serious health problems or death
- StatusClosed by FDA, ended 2015-10-13
- DatesFirm started it 2013-11-09. In FDA's enforcement report 2014-01-22.
- Sold inWorldwide 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.
- Amount1,065,783 units
- Codes3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
- FirmUSPlabs, LLC, Dallas, TX · Voluntary: Firm initiated
Products we list
None. We tie a recall to a product only by a barcode printed in the recall, and this one names none we list. That does not mean the recalled food is missing from our listings.
From FDA's enforcement report, via openFDA (CC0): raw data for this recall. FDA's own Enforcement Report search finds it by its number, F-1371-2014. Class meanings: FDA.