From Cayman Public Health Department

Following recall by the manufacturers of the dietary supplement OxyElite Pro in the United States, the Medical Officer of Health Dr. Kiran Kumar is advising persons to immediately cease taking these supplements.

Additionally all local distributors and retailers are being advised to immediately remove the product from their stocks.

On November 9, 2013, USPSLabs LLC, of Dallas, Texas announced the recall of certain OxyElite Pro dietary supplement products.

The company took this action after receiving a letter from the United States (U.S.) Food and Drug Administration (FDA) stating that the products have been linked to liver illnesses, and that there is a reasonable probability that the products are adulterated.

Along with the Centers for Disease Control and Prevention (CDC), and state and local health officials in the United States, the FDA is investigating more than 50 cases of acute non-viral hepatitis linked to the dietary supplements.

As of 13 November 2013, there have been 62 cases of acute non-viral hepatitis with an unknown cause subsequent to the use of a weight loss or muscle building dietary supplement identified nationally, with most of them being in the State of Hawaii. Fifty-one used the dietary supplement products labeled as OxyElite Pro during the 60 days prior to illness.

In a FDA review of 46 medical records submitted by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. 17 of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking.

One death has occurred among these patients, another patient has had a liver transplant, and others await liver transplants.

The products involved in the recall include:

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

Although currently, FDA is not aware of international shipments of the recalled product to foreign distributors or direct international consignees, the FDA is aware that the affected products were available through internet sales. Hence to protect the public’s health, Dr. Kumar has advised that anyone in possession of OxyElite Pro and VERSA-1 dietary supplements produced by USP Labs LLC, should immediately discard them. Individuals who believe they have been harmed by using a dietary supplement should also contact their health care practitioner.

A detailed overview of the status of the investigation in the US and associated recall details has been posted online by the FDA on 10 November 2013: http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm370849.htm

What do consumers need to do?

The FDA advises consumers to discontinue using any dietary supplement products labeled as Oxy Elite Pro and VERSA-1 while the investigation continues. OxyElite Pro and VERSA-1 are distributed by USP Labs LLC of Dallas, Texas, and are sold nationwide through retail stores, mail orders and direct delivery.

Who should be contacted?

Consumers can contact USP Labs at 1(800) 890-3067 (Monday-Friday, 9 am – 5 pm EST) or by e-mail at [email protected]<mailto:[email protected]>.

Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

If you think you have suffered a serious harmful effect or illness from a dietary supplement, your health care provider can report this by calling FDA’s MedWatch hotline at 1-800-FDA-1088 or visit http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm

The MedWatch Program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

Consumers may also report an adverse event or illness they believe to be related to the use of a dietary supplement by calling FDA at 1-800-FDA-1088 or visit http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm.

FDA would like to know when a product may be related to a medical problem even if you are unsure the product caused the problem or even if you do not visit a doctor or clinic.