November 19, 2013 – USPlabs, LLC is expanding its nationwide recall of OxyElite Pro dietary supplements to include Raspberry Lemonade Super Thermo Powder. These products contain aegeline, an ingredient the U.S. Food & Drug Administration (FDA) has determined to be illegal to use in dietary supplements. USPlabs initiated the OxyElite Pro recall earlier this month after the supplement was linked to a nationwide outbreak of hepatitis and liver failure.
Update 4/16/14: Earlier this month, a panel of federal judges denied a motion by the makers of OxyElite Pro and Jack3d to transfer and consolidate a number of products liability lawsuits to federal court in Philadelphia. The litigation contends that the supplements contained altered ingredients that were unsafe and unapproved by the FDA, leading to a nationwide hepatitis outbreak. Click here to learn more.
Free Confidential Case Evaluation: If you or a loved one has been injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
UPDATE: USPlabs Recalls Raspberry Lemonade OxyELITE Pro Super Thermo Powder
Epidemiological evidence has shown that OxyElite Pro can cause users to develop liver damage, liver failure, acute hepatitis, and other serious side effects. Dallas, TX-based USPlabs agrees with the FDA that a national recall is appropriate to limit adverse events associated with these products. OxyElite Pro was distributed nationwide through retail stores, mail orders and direct delivery.
The following products are subject to the nationwide OxyElite Pro recall:
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
To date, no other products manufactured by USPlabs have been recalled. Consumers who have purchased OxyElite Pro should discontinue use immediately and return it to the place of purchase for a full refund. Consult your physician immediately if you have experienced any adverse effects.
OxyElite Pro Found to be Adultered
On October 11, 2013, the FDA sent a Warning Letter to USPlabs stating that OxyElite Pro and another supplement made by the company, VERSA-1, contain an ingredient called aegeline which has no history in the food supply and has not been properly tested for safety. According to the FDA:
“In the absence of a history of use or other evidence of safety establishing that aegeline, when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, OxyElite Pro and VERSA-1 are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). FDA is aware of no history of use or other evidence of safety establishing that aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of OxyElite Pro and Versa-1.”
Do I Have an OxyElite Pro Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by OxyElite Pro side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.