The U.S. Food and Drug Administration just announced that USPlabs LLC, of Dallas, Texas, is recalling some of its OxyElite Pro dietary supplement products. USPlabs issued the recall after it had received a letter from the agency indicating that OxyElite Pro products had been associated with liver illnesses and that there exists a reasonable probability that these products are adulterated.
The letter also advised USPlabs that if it did not implement a voluntary recall, the agency could legally mandate USPlabs to immediately stop distributing the OxyElite Pro supplements and advise other parties to cease distributing the supplements, as well.
This is the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter. Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor said, “We took this step to ensure that adulterated and harmful products do not reach the American public…. We will continue to work with our state, industry, and regulatory partners to prevent such products from reaching the public.”
The products being recalled are:
- OxyElite Pro Super Thermo Capsules: Two-count—UPC 094922417275; 10 count—UPCs 094922417251 and 094922417268; 21-count—UPC 094922426604; 90-count—UPC 094922395573; 90-count “Pink label”—UPC 094922447906; 180-count—UPC 094922447852.
- OxyElite Pro Ultra-Intense Thermo Capsules: Three-count—UPCs 094922447883 and 094922447876; 90-count—UPC 094922395627; 180-count—UPC 094922447869.
- OxyElite Pro Super Thermo Powder: Fruit Punch 0.15-ounce—UPCs 094922417237 and 094922447517; Fruit Punch 4.6-ounce—UPC 094922426369; Fruit Punch 5-ounce—UPC 094922447487; Blue Raspberry 4.6ounce—UPC 094922426376; Grape Bubblegum 4.6-ounce—UPC 094922447500; Green Apple 4.6-ounce—UPC 094922426499.
The November 6th FDA letter advised USPlabs about findings indicating a link between use of the recalled OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also stated that other cases of liver damage had been reported following use of the recalled OxyElite Pro products in other states. A review of 46 medical records submitted to the FDA by the Hawaii Department of Health indicated that 27 patients—58 percent—had taken a dietary supplement labeled as OxyElite Pro prior to becoming sickened. Of these, 27 patients—63 percent—reported that OxyElite Pro was the only dietary supplement they were taking.
The Associated Press (AP) noted that hepatitis illnesses have been associated to the weight loss and muscle building supplement and, according to the FDA, to date, one death has occurred among the patients. Another patient required a liver transplant and others are awaiting liver transplants.
The FDA previously issued a warning letter to USPlabs October 11th informing the company that OxyElite Pro and VERSA-1, another dietary supplement, were deemed to be adulterated. Both products contain aegeline, a new dietary ingredient (according to the FDA, this is an ingredient not marketed in the U.S. before October 15, 1994) that lacks a history of use or other evidence of safety. The letter also indicated that the firm’s failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.
The FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
As we’ve written, the U.S. Centers for Disease Control and Prevention (CDC) issued recommendations, including that, as part of a thorough examination, clinicians with patients diagnosed with acute hepatitis be asked about their use of dietary supplements. Hepatitis symptoms, regardless of type, are similar and can include fever, fatigue, nausea, vomiting, abdominal pain, joint pain, and yellow eyes,