WASHINGTON, March 18, 2015 /PRNewswire/ -- USPLabs Inc. has been made aware that U.S. Senators Dick Durbin (D-IL), Dianne Feinstein (D-CA), and Richard Blumenthal (D-CT) have sent a letter to the Food and Drug Administration (FDA) requesting an investigation into Oxy ELITE Pro Super Thermogenic products.
The letter is related to a Public Notification issued on Saturday, February 28, 2015, by the Center for Drug Evaluation and Research (CDER) regarding the contamination of a dietary supplement product labeled as OxyElite Pro Super Thermogenic (OEP) with a prescription drug active ingredient, fluoxetine.
In response, USPLabs has made the following statement:
"An investigation has determined that the product in question was not manufactured or distributed by or for USPLabs. It is a counterfeit. As soon as this was discovered, USPLabs immediately alerted the FDA to the counterfeit through the attached letter.
"The genuine OEP has not been manufactured since October 2013. OEP has always been labeled with a three year expiration date. The last lot manufactured had an expiration date of 10/16. The counterfeit product expiration date of 04/17 is therefore obviously fraudulent.
"The genuine OEP, made in capsules, uniformly had lot numbers beginning with the numeral "4." The counterfeit product lot number of 216732 is therefore obviously fraudulent. The Company has verified that no OEP product (or other Company product) has ever had the lot number of 216732.
"Neither USPLabs nor its contract manufacturers have ever ordered or in any way handled fluoxetine for any purpose of any kind.
"USPLabs is also a victim of these counterfeit products. We continue to work to educate consumers that they should purchase supplements only from authentic and verified sources. We would like to work with the FDA to help prevent the distribution of counterfeit versions of its dietary supplement products."
SOURCE USPLabs
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