FDA: Lab is recalling diet pills linked to liver damage

Recall from USPlabs of Dallas

WASHINGTON - A diet pill is being recalled because of links to liver damage.

The Food and Drug Administration says USPlabs of Dallas is recalling OxyElite Pro products thought to have impurities. The dietary supplement is used for weight loss and muscle-building.

After linking the products to dozens of hepatitis and liver failure cases in Hawaii, investigators linked the pills to cases in a number of other states, too.

The FDA says one of the patients died, another needed a liver transplant and others are now awaiting liver transplants.

The recall followed a letter from the FDA notifying USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order an immediate halt to distribution of the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act.

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

If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their health care provider can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088 or by reporting it online. 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 can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 7 a.m. - 3 p.m. MST) or info@usplabsdirect.com.

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