Food Recall Check
Class I · High risk Terminated Initiated Nov 9, 2013 (13 years ago)

USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs recall

Recalled by USPlabs, LLC · Dallas, TX, United States

Class I — High risk. Reasonable probability of serious harm or death.

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.

See the recall's own reason text for the specifics. All other reasons recalls.

What 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.

Quantity: 2,166,328 units

Food: Dietary supplements

Lot codes, dates and UPCs

A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.

2 count capsules, UPC # 094922417275; 10 count capsules, UPC # 094922417251; 10 count capsules, UPC # 094922417268; 21 count capsules, UPC # 094922426604; 90 count capsules, UPC # 094922395573; 90 count capsules "Pink Label", UPC # 094922447906; 180 count capsules, UPC # 094922447852

Where it was sold

FDA's distribution note: 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.

Do not eat it. Class I means FDA judged there is a reasonable probability of serious illness or death. If the brand, size and lot or date code on your package match, throw the product away or return it to the store for a refund, and clean any surface or container it touched. If anyone has eaten it and feels unwell, contact a doctor and mention the recall. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.

Recalling firm
USPlabs, LLC
Initiated by
Voluntary: Firm initiated
Recall initiated
Nov 9, 2013
In FDA report of
Jan 22, 2014
Terminated
Oct 13, 2015
FDA recall number
F-1370-2014 · event 66813
Official record
FDA enforcement report search

Also recalled with it (6 more products)

FDA files each product of one recall action separately; these share the same FDA event.

Class I · High risk Terminated Other

USPlabs OxyELITE Pro Ultra-Intense Thermo Advanced Formula…

Reason 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…

USPlabs, LLC F-1371-2014
Class I · High risk Terminated Other

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine…

Reason 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…

USPlabs, LLC F-1372-2014
Class I · High risk Terminated Other

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine…

Reason 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…

USPlabs, LLC F-1373-2014
Class I · High risk Terminated Other

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine…

Reason 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…

USPlabs, LLC F-1374-2014
Class I · High risk Terminated Other

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine…

Reason 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…

USPlabs, LLC F-1375-2014
Class I · High risk Terminated Other

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine…

Reason 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…

USPlabs, LLC F-1376-2014

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