OEP Product Is Counterfeit

Mar 01, 2015, 02:16 ET from USPlabs

WASHINGTON, March 1, 2015 /PRNewswire-USNewswire/ -- USPlabs has notified the Food and Drug Administration (FDA) of the following and states that media reports saying that a company product contains Prozac are false:

On Saturday, February 28, 2015, the Center for Drug Evaluation and Research (CDER) issued a Public Notification on the contamination of a dietary supplement product labeled as OxyElite Pro Super Thermogenic (referred to below as "OEP") with a prescription drug active ingredient, fluoxetine. USPlabs immediately conducted an investigation and determined that the product shown in the Public Notification and tested by FDA was not manufactured or distributed by or for the Company. It is a counterfeit.

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 has ever ordered or in any way handled fluoxetine for any purpose of any kind.

The Company has encountered counterfeit versions of its dietary supplement products in the past, and has reported these problems to FDA as well as to State and other Federal officials.

Although USPlabs discontinued the manufacture and distribution of its products containing DMAA in October 2013, other companies did not. Numerous dietary supplement products containing DMAA are still available through the internet. The Department of Defense Human Performance Resource Center website lists 43 such products, and the National Medicines Comprehensive Database lists 313. A Brazilian website, as example, offers OEP for sale and that may well have been the source of the counterfeit product that FDA tested. The Supplement Facts for the counterfeit OEP product shown in the Brazilian website are not the same as the genuine USPlabs version. And, in fact, online complaints about the Brazilian counterfeit OEP can be found identified by lot number 216732 and expiration date 04/17 -- the same identifiers as the counterfeit tested by FDA.

USPlabs has offered to work with the FDA to help prevent the distribution of counterfeit versions of its dietary supplement products.