Navigation Links
Linked to Liver Failure, Diet Supplement OxyElite Pro Recalled; Parker Waichman LLP Commends FDA for Invoking Rarely Used Enforcement Power in Letter to Supplements Maker
Date:11/13/2013

New York, New York (PRWEB) November 13, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, notes that Dallas-based USPlabs LLC is recalling certain OxyElite Pro dietary supplement products after receiving a letter from the U.S. Food and Drug Administration (FDA) stating that the products had been linked to liver illnesses and that there is a “reasonable probability” that the products were adulterated, according to a Nov. 10, 2013, press release issued by the FDA. The letter also notified USPlabs that if it did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the products, the press release added, noting that this marked only the second time that the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA). The act was signed into law on Jan. 4, 2011, according to the FDA’s Food Guidance & Regulation webpage, last updated on Nov. 12.

“The FDA took this step to ensure that adulterated products do not reach the American public,” said Gary P. Falkowitz, a Managing Attorney at Parker Waichman LLP. “We support the FDA in this decision to show its willingness to use every power at its disposal to protect the American public from an allegedly dangerous supplement.”

According to the FDA press release, products that are part of this recall are OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder (available in the flavors fruit punch, blue raspberry, grape bubblegum and green apple). A full list of the products and their UPC codes can be found on the related page on the FDA website.

As further noted in its press release, the FDA notified USPlabs about findings indicating a link between the use of OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA release also noted that cases of liver damage following the use of these OxyElite Pro products had also been found in a number of other states.

It added that, in a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, 27 patients, or 58 percent, had taken a dietary supplement named OxyElite Pro before they became ill; 17 of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement that they were taking. One death has occurred among these patients, one patient has undergone a liver transplant, and others require transplants but are waiting for the organs to become available, the press release noted.

In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another of its dietary supplements, called VERSA-1, had been deemed by the agency as “adulterated.” The letter pointed out that the products in question included aegeline, a new dietary ingredient that “lacks a history of use or other evidence of safety.” The letter also stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

If you or someone you know has taken OxyElite Pro dietary supplement products, you may have valuable legal rights. To discuss your case with one of our lawyers, please view our website or call 1-800-LAW-INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary P. Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636
http://www.yourlawyer.com

Read the full story at http://www.prweb.com/releases/oxyelitepro_recall_fda/11/prweb11330967.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Sobriety, spirituality linked for teens in treatment
2. Da Vinci Robot Lawsuit News: Bernstein Liebhard LLP Notes FDA Finding that Robotic Surgery Complications Linked to da Vinci Robot Doubled in Past Year
3. First genetic mutations linked to atopic dermatitis identified in African-American children
4. Endometriosis risk linked to 2 pesticides
5. Stem cells linked to cognitive gain after brain injury in preclinical study
6. Diabetes Increase Linked to Long Naps Released by Health News Wires
7. Earlier onset of puberty in girls linked to obesity
8. Increasing rate of knee replacements linked to obesity among young, researchers say
9. RNA build-up linked to dementia and motor neuron disease
10. Weight at time of diagnosis linked to prostate cancer mortality
11. Male birth defect is weakly linked to pesticide exposure, Stanford-led study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/13/2016)... (PRWEB) , ... February 13, 2016 , ... ... School of Nursing with an in-kind gift of a VeinViewer® Vision vein ... as they learn how to start an IV and draw blood, combining technology ...
(Date:2/13/2016)... ... February 13, 2016 , ... DDi ... Management Solution Providers list for its expertise in eClinical Solutions. DDi has built ... serve the technology needs of global clients. DDi provides smarter technology for Clinical ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, Ryan & ... purpose of these scholarships is to encourage applicants to pursue a degree in their ... these two parishes. , “We have available jobs in St. Landry and Evangeline ...
(Date:2/12/2016)... ... February 12, 2016 , ... CDRH Enforcement Trends: , Back to the Future , ... , As Winston Churchill said, “Those who don’t learn from history are doomed to ... expect when they come knocking this year. But that takes time. , Take a ...
(Date:2/12/2016)... , ... February 12, 2016 , ... As a former ... schedule, a demanding job, and no time to decompress, Rabinowitz found herself drawn to ... to meditation for its impact on her life, implementing a 20-minute-per-day meditation practice with ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... -- - Cardiac Marker Diagnostic Testing ... Cancer Therapy. - European Point of Care Diagnostic ... - Key Diagnostic Testing Markets. - Molecular Diagnostics ... Testing. - Molecular Diagnostics in Infectious Disease Testing. ... Products World Markets. - Point of Care Diagnostic ...
(Date:2/11/2016)... Feb. 11, 2016 Stem cells are primitive ... by self-renewal and the capacity to differentiate into mature ... discovery, as the first mouse embryonic stem cells were ... until 1995 that the first culturing of embryonic stem ... were not produced until 2006 As a result of ...
(Date:2/11/2016)... 11, 2016 Laboratory glassware and ... laboratories. These may range from microscope slides to large ... made from borosilicate glass because of its low weight ... other hand, started gaining popularity over the past decade ... replace glass with plastic in several applications due to ...
Breaking Medicine Technology: