November 12, 2013
Concord, NH – The New Hampshire Department of Health and Human Services (DHHS), Division of Public Health Services is reminding residents to stop using any supplement labeled OxyElite Pro because it has been linked to hepatitis (disease of the liver) and liver failure. USPLabs LLC of Dallas, TX, is voluntarily conducting a national recall of all lots and sizes of OxyElite Pro dietary supplement products (listed below). These products contain Aegeline, a synthesized version of a natural extract from the Bael Tree. There is an ongoing investigation related to this product being conducted by the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the Hawaii Department of Health (DOH).
The dietary supplement, used for weight loss or muscle building, is distributed across the country, though cases have been concentrated in Hawaii. The Hawaii DOH and the CDC have reported 56 patients affected with acute hepatitis in 13 states. One death and two liver transplants in the U.S. have been linked to the use of this product.
“It is important that all consumers who may have purchased these supplements discontinue using them and return them to the place where they were purchased,” said Dr. José Montero, Director of Public Health at DHHS. “At this time, DHHS does not know what retailers received these products, so we are asking retailers to check their stock and remove these products from their shelves. We will provide additional information as we receive it.”
Besides being available for purchase online, these products were distributed by GNC, Vitamin Shoppe, and Vitamin World stores. The list of recalled products includes:
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
Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay- or gray-colored bowel movements, joint pain, yellow eyes, and jaundice. Consumers who experience these symptoms and have used this dietary supplement should contact their health care provider.
For more information, visit the Food and Drug Administration website at http://www.fda.gov/Safety/MedWatch/. Consumers can contact USPLabs at 1-800-890-3067 (Monday–Friday, 9 am to 5 pm EST) or firstname.lastname@example.org. Adverse reactions may be reported to the FDA MedWatch Adverse Event Reporting program at http://www.fda.gov/medwatch/getforms.htm, or by calling FDA’s MedWatch Hotline at 1-800-FDA-1088. To reach the DHHS Division of Public Health Services, please call 603-271-4496.