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.
Product description
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
Lot numbers, UPCs & expiration codes
Fruit Prunch 0.15 oz, UPC #094922417237 and UPC #094922447517; Fruit Punch 4.6 oz, UPC #094922426369; Fruit Punch 5 oz, UPC #094922447487
Where it was sold
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.
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1372-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 9, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 645,826 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- USPlabs, LLC
Original FDA data
Every field from FDA enforcement report F-1372-2014, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 66813
- Address
- 10761 King William Dr
- 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
- Postal code
- 75220-2445
- Report date
- Jan 22, 2014
- Product type
- Food
- Recall number
- F-1372-2014
- Classification
- Class I
- Recalling firm
- USPlabs, LLC
- Product quantity
- 645,826 units
- Termination date
- Oct 13, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- 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.
- Recall initiation date
- Nov 9, 2013
- Initial firm notification
- Press Release
- Center classification date
- Jan 15, 2014