Advice line: 1890 33 66 77

OxyELITE Pro and VERSA-1 Supplements Associated with Liver Disease

Wednesday, 13 November 2013

Summary
Category 1:

For Action

Alert Notification:

2013.19

Product:

OxyELITE Pro Super Thermo Capsules;
OxyELITE Pro Ultra-Intense Thermo Capsules;
OxyELITE Pro Super Thermo Powder;
VERSA-1.

Batch Code:

All batch codes; all best before dates; all pack sizes.

Country Of Origin:

United States

Message:

USP Labs LLC, Dallas, USA is recalling OxyELITE Pro supplements, which are marketed for “energy boost, muscle building and weight loss”. This follows reports in the USA of 56 cases of liver disease that may be related to the consumption of these supplements. One person died and two people required liver transplants.  
VERSA-1 is also produced by USP Labs LLC.  Although VERSA-1 has not been associated with liver disease, both supplements contain the ingredient aegeline. The Food Safety Authority of Ireland (FSAI) advises consumers not to consume OxyELITE Pro or VERSA-1 as aegeline cannot be excluded as a cause of illness.
OxyELITE Pro has been on sale in Ireland.  The implicated supplements are sold via the internet and may be available through outlets that specialise in “sports supplements”.

Nature Of Danger:

Risk of developing acute non-viral hepatitis (liver disease).

Action Required:

Inspectors:

EHOs are requested to check relevant businesses including gyms, sport supplement retailers and Irish businesses selling supplements from websites. All batches of OxyELITE Pro and VERSA-1 supplements must be removed from sale and a point of sale recall notice displayed. Please notify the FSAI (rapidalert@fsai.ie) of any implicated supplements found on sale and provide the supply chain details.

Manufacturers, wholesalers, distributors, caterers & retailers:

Businesses are requested to remove the affected products from sale and clearly display a point of sale recall notice advising customers not to consume OxyELITE Pro and VERSA-1 supplements.

Consumers:

Consumers are advised not to consume OxyELITE Pro and VERSA-1 supplements. Consumers who may have already taken these products and are feeling unwell should seek medical advice.