The FDA (Food and Drug Administration) announced on Sunday that USPlabs is recalling OxyElite Pro sports supplement products because it has been linked to an outbreak of liver illnesses, including one resulting in death.
The action follows a letter the FDA sent Wednesday notifying USPlabs if it did not recall the supplements voluntarily, that the FDA would order the company to stop distribution of the products immediately and notify other distributors and retailers to stop selling them.
This was posted on the FDA website
AUDIENCE: Health Professional, Consumer
ISSUE: The FDA, along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH), are investigating a growing number of reports of acute non-viral hepatitis in Hawaii. The Hawaii DOH has reported that 24 of these cases share a common link to a dietary supplement product labeled as OxyElite Pro.
BACKGROUND: OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nation-wide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. There have been 29 cases of acute non-viral hepatitis with an unknown cause identified in the state of Hawaii. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. CDC is also looking at other cases of liver injury nationwide that may be related. 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.
The epidemiological investigation is being conducted by the Hawaii DOH and the CDC. As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients. Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.
RECOMMENDATION: The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
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
–Raspberry Lemonade 4.6 oz. UPC #094922447494
As of Wednesday, the Centers for Disease Control and Prevention said it had 56 confirmed cases of liver illnesses since April 1 linked to OxyElite Pro. The FDA said Sunday that it continues to warn consumers not to take any supplements labeled OxyElite Pro or VERSA-1. The agency said consumers who think they have been harmed should contact a doctor. They can file a report with the FDA by calling 1-800-FDA-1088.
via USA Today