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Recall Observatory FDA recall evidence

Food product

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Fruit Punch Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: Fruit Punch 0.15 oz; Fruit Punch 4.6 oz; and Fruit Punch 5 oz

F-1372-2014

November 09, 2013

Class I

Product summary

Firm
USPlabs, LLC
Event
Event 66813
Status
Terminated
Classification
Class I
Quantity
645,826 units
Official record key
food-enforcement:F-1372-2014

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: Fruit Prunch 0.15 oz, UPC #094922417237 and UPC #094922447517; Fruit Punch 4.6 oz, UPC #094922426369; Fruit Punch 5 oz, UPC #094922447487

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

    reason.no_named_rule · v1.0.0

    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.