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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/oep-product-is-counterfeit-300043232.html
SOURCE USPlabs