Showing posts with label Aegeline. Show all posts
Showing posts with label Aegeline. Show all posts

Wednesday, November 13, 2013

Ireland: OxyELITE Pro and VERSA-1 Recalled Due to Liver Disease

OxyELITE Pro and VERSA-1 Supplements Associated with Liver Disease. 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 Super Thermo capsules; OxyELITE Pro Ultra-Intense Thermo capsules; OxyELITE Pro Super Thermo powder and VERSA-1 have been on sale in Ireland.  The implicated supplements are sold via the internet and may be available through outlets that specialise in “sports supplements”.
There is a danger of developing acute non-viral hepatitis (liver disease).
Inspectors 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 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 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.


Sunday, November 10, 2013

USPlabs Recalls OxyElite Pro and Other Products

 USPlabs LLC, Dallas, TX is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products listed below. These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.
Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii.  Investigations are ongoing into a potential causal relationship.  The Company agrees with FDA that a national recall is appropriate as a precautionary measure. Product was distributed nationwide through retail stores, mail orders and direct delivery.
OxyElite Pro Super Thermo capsules
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
OxyElite Pro Ultra-Intense Thermo capsules
3 count capsules UPC #094922447883
3 count capsules UPC #094922447876
90 count capsules UPC #094922395627
180 count capsules UPC #094922447869
OxyElite Pro Super Thermo Powder
Fruit Punch 0.15 oz UPC #094922417237
Fruit Punch 0.15 oz UPC #094922447517
Fruit Punch 4.6 oz UPC #094922426369
Fruit Punch 5 oz. UPC #094922447487
Blue Raspberry 4.6 oz UPC #094922426376
Grape Bubblegum 4.6 oz UPC #094922447500
Green Apple 4.6 oz. UPC #094922426499
No other products produced by USPlabs are subject to recall. Consumers who have purchased the products should immediately discontinue use of the product and return it to where they purchased it for a refund. Contact your health care professional if you have experienced any adverse effects.
Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 am - 5 pm EST) or info@usplabsdirect.com. Adverse reactions may be reported to the FDA MedWatch Adverse Event Reporting program online at http://www.fda.gov/medwatch/getforms.htm, by regular mail, or by FDA's MedWatch Hotline 1-800-FDA-1088.