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 Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.
Lot numbers, UPCs & expiration codes
3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
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-1371-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 9, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 1,065,783 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- USPlabs, LLC
Original FDA data
Every field from FDA enforcement report F-1371-2014, 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
- 3 count capsules, UPC #094922447883; 3 count capsules UPC #094922447876; 90 count capsules, UPC #094922395627; 180 count capsules UPC #094922447869
- Postal code
- 75220-2445
- Report date
- Jan 22, 2014
- Product type
- Food
- Recall number
- F-1371-2014
- Classification
- Class I
- Recalling firm
- USPlabs, LLC
- Product quantity
- 1,065,783 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 Ultra-Intense Thermo Advanced Formula DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), sold in the following sizes: 3 count; 90 count; and 180 count.
- 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