USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEM...

FDA Recall #F-1374-2014 — Class I — November 9, 2013

Recall #F-1374-2014 Date: November 9, 2013 Classification: Class I Status: Terminated

Product Description

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) GRAPE BUBBLEGUM Manufactured for USPlabs, LLC (Dallas, TX 75220)

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.

Recalling Firm

USPlabs, LLC — Dallas, TX

Classification

Class I — A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Product Type

Food

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated