Recalls / Class I
Class IF-1373-2014
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 Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) BLUE RASPBERRY Manufactured for USPlabs, LLC (Dallas, TX 75220)
- Type
- Food
- Affected lot / code info
- UPC #094922426376
- Quantity
- 71,499 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-1373-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.