UPDATED 09/02/2014. Voluntary nationwide recall expanded to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814, and Lot #11414re5516.
ISSUE: Regeneca Worldwide a division of VivaCeuticals, Inc., is conducting a voluntary nationwide recall of its RegeneSlim appetite control dietary supplement, lot # EX0616R15814 and lot #11414RE5516, because FDA analysis confirmed the presence of DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
BACKGROUND: RegeneSlim is purchased by and distributed through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and retail sales. RegeneSlim is packaged in approximately 3 ½” by 3” green and white sachets that contain 2 capsules, with the name RegeneSlim displayed prominently on the front of the sachet.
RECOMMENDATION: Consumers who have purchased affected RegeneSlim lot numbers are advised to immediately stop using the product and return it to the place of purchase. Consumers with questions may contact the company at 1-949-281-2600 between the hours of 9 a.m. and 6 p.m. PDT. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using RegeneSlim.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/06/2014 - Press Release - Regeneca Worldwide]
[06/25/2014 - Consumer Update - DMAA - FDA]