Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA

[Posted 09/13/2013]

AUDIENCE: Consumer

ISSUE: Ge Pharma, LLC is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, because they contain 1,3 dimethylamylamine (DMAA). DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.

The FDA has warned that DMAA is potentially dangerous to health. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. A number of adverse effects associated with DMAA containing dietary supplements have been reported to the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.

BACKGROUND: These products were distributed nationwide and was sold via telephone and email. They are packaged in a white, 600 gram container with an expiration date of 2/2015.

RECOMMENDATION: Consumers who may have purchased the affected lot numbers of Creafuse should immediately discontinue use of the product and contact their health care professional if they have experienced any adverse effects. Consumers can contact GE Pharma LLC at gerry@gepharma.com or call 1-203-675-1057, Monday – Friday, 11 a.m. – 5 p.m. EST to receive further instructions for disposing, returning the product(s), refunds, credits, exchanges, or with any questions.

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

[09/12/2013 - Press Release - Ge Pharma, LLC]
[09/12/2013 - Product Labels - Ge Pharma, LLC]