Food Recalls (FDA)

Raspberry Lemonade OxyELITE Pro Super Thermo Powder

Published on Wednesday, 20 November 2013 01:44

FG_AUTHORS: FDA

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Update: USPlabs LLC Announces a Recall of OxyELITE Pro Dietary Supplements Due to Possible Health Risk
Recall expanded to include: Raspberry Lemonade OxyELITE Pro Super Thermo Powder

 

Contact:
Consumer:
(800) 890-3067
Email: info@usplabsdirect.com
 

FOR IMMEDIATE RELEASE - November 19, 2013 - 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
  • Raspberry Lemonade 4.6 oz. UPC #094922447494

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.

 

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Photo: Product Labels

Initial Press Release

FDA Press

Recalled Product Photos Are Also Available on FDA's Flickr Photostream.

    

Read More » http://www.fda.gov/Safety/Recalls/ucm375740.htm