FDA recall F-1370-2014

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2013-11-09

Report date

2014-01-22

Termination date

2015-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1370-2014