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FDA (Food enforcement)Recalled 2013-11-09closedclass i

USPlabs, LLC: 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 foll

Is my product affected?

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

  • UPC 094922417237
  • UPC 094922447517
  • UPC 094922426369
  • UPC 094922447487

Check against the official notice below — it lists the full affected range.

What happened

USPlabs, LLC is recalling OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System dietary supplement in Fruit Punch flavor due to the presence of Aegeline, which has been associated with serious adverse health events including serious liver damage and acute liver failure. The recall was initiated following a notification letter from the FDA. Approximately 645,826 units have been affected and distributed worldwide, including to Ecuador, Russia, the UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.

The recalled products include Fruit Punch 0.15 oz (UPC #094922417237 and UPC #094922447517), Fruit Punch 4.6 oz (UPC #094922426369), and Fruit Punch 5 oz (UPC #094922447487). The source document does not specify what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: 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. Quantity: 645,826 units Lot/code info: Fruit Prunch 0.15 oz, UPC #094922417237 and UPC #094922447517; Fruit Punch 4.6 oz, UPC #094922426369; Fruit Punch 5 oz, UPC #094922447487

Source

Official record: FDA (Food enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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