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USPlabs Dietary Product Recall: FDA Pulls Back Additional Raspberry Lemonade OxyElite Pro Thermo Powder (LIST)

Nov 20, 2013 02:41 PM EST | By Justin Stock

USPlabs LLC has extended its recall of OxyElite Pro products to include Raspberry Lemonade OxyElite Pro Thermo Powder according to a press release from The United States Food and Drug Administration reported Tuesday.

The products were sent to retail stores, via mail orders, and straight to specific destinations.

"These products contain Aegeline, a synthesized version of a natural extract from the Bael tree," the company said in a statement. "Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii. Investigations are ongoing into a potential causal relationship. The Company agrees with FDA that a national recall is appropriate as a precautionary measure."

The original product recall included OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder.

According to the administration, USPlabs of Dallas was informed about the cases in a letter Nov. 6 after a connection was found between several OxyElite Pro products and liver sicknesses in Hawaii where one individual perished, while another obtained a liver transplant out of 27 people who reported taking the affected product.  Blemish livers have also been reported in other states.

The FDA asked USPlabs in an Oct. 11, 2013 letter to stop production of OxyElite Pro, and VERSA-1 since they have aegeline, a substance that was not promoted in the United States prior to the establishment of the dietary and supplement health and education act of 1994 on Oct. 15, 1994 the administration reported.

Users can also contact USPlabs at 1-800-890-3067 Monday through Friday from 9 a.m. to 5 p.m. eastern time or by e-mailing the company at info@usplabs.com.

Users who have severe reactions to the product can contact the adminstration's MedWatch Adverse Event Reporting program on the agency's website, through snail mail, or by calling 1-800-FDA-1088.

Click here for a full list of the recalled products.

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