The products have been linked to liver illnesses
of ConsumerAffairs
USPlabs of Dallas, Texas, is recalling certain of its OxyElite Pro dietary supplement.
The action was taken after the company was notified by the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated.
The company was also warned that if it did not initiate a voluntary recall, the FDA could -- by law – order it to stop distributing the dietary supplements and notify other parties to stop distributing them.
The products involved in the recall include:
OxyElite Pro Super Thermo capsules
- two 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
- three count capsules UPC #094922447883
- three 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
FDA also notified USPlabs about findings indicating a link between the use of the above listed OxyElite Pro products and a number of liver illnesses reported in Hawaii. The agency noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.
A review of 46 medical records indicates 27 patients (58%)) had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (63%) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.
In a warning letter issued to USPlabs on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.
FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or info@usplabsdirect.com.