Medindia

X

Globe All Wellness, LLC Issues a Voluntary Recall of Dietary Supplement Found to Contain an Undeclared Drug Ingredient

Wednesday, May 25, 2011 General News J E 4
Advertisement

HOLLYWOOD, Fla., May 25, 2011 /PRNewswire/ -- Globe All Wellness, LLC has been informed by the Food and Drug Administration (FDA) that one of the company's weight loss dietary supplements that was sold by a seller that was not authorized by Globe All Wellness, LLC to sell the product contains an undeclared drug ingredient. FDA lab analyses of this dietary supplement was found to contain undeclared Sibutramine. The FDA has not approved Sibutramine; therefore, the safety and effectiveness of this product is unknown.

All lots of the following dietary supplement products are being recalled:

  • Slim Xtreme™ Herbal Slimming Capsule 30 Capsules/Bottle

The products listed above were sold and distributed nationwide via the Internet and at the company's headquarters in Hollywood, Florida. The FDA advises that this product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

No illnesses or injuries have been reported to Globe All Wellness, LLC to date in connection with this product.

With abundance of caution, Globe All Wellness, LLC is voluntarily recalling all lots of SLIM XTREME™ from the market as a precautionary measure.

This recall does not affect the sales and distribution of Globe All Wellness, LLC's other products such as SLIM XTREME GOLD™ or GELSLIM™.

Globe All Wellness, LLC has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Globe All Wellness, LLC is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers are advised to return the above product to:

Globe All Wellness, LLC2854 Stirling Rd Suite GHollywood, FL 33020

Consumers with questions may contact the company at (954) 922-1133 Monday through Friday from 9:00am to 4:00pm EDT for instructions on the return process.

Any adverse reactions experienced with the use of this product should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/Safety/MedWatch/default.htm.

Media Contact:

Eran Hamami(954) 922-1133

This press release was issued through eReleases(R).  For more information, visit eReleases Press Release Distribution at http://www.ereleases.com.

SOURCE Globe All Wellness, LLC

Advertisement


Advertisement

You May Also Like

Advertisement
View All

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
User Avatar
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions
s
Turn Down the Sound: Kessler Institute Offers Tips...
S
Wedding Ideas - How to Honor a Deceased Parent at ...