Class IF-1371-2014

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

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.

Type: Food
Affected lot / code info: 3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
Quantity: 1,065,783 units

Why it was recalled

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.

Recalling firm

Firm: USPlabs, LLC
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 10761 King William Dr, Dallas, Texas 75220-2445

Distribution

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.

Timeline

Recall initiated: 2013-11-09
FDA classified: 2014-01-15
Posted by FDA: 2014-01-22
Terminated: 2015-10-13
Status: Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-1371-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.