USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.
Reported: January 22, 2014 Initiated: November 9, 2013 #F-1370-2014
Product Description
USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.
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.
Details
- Recalling Firm
- USPlabs, LLC
- Units Affected
- 2,166,328 units
- 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.
- Location
- Dallas, TX
Frequently Asked Questions
What product was recalled? ▼
USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules.. Recalled by USPlabs, LLC. Units affected: 2,166,328 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on January 22, 2014. Severity: Critical. Recall number: F-1370-2014.
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