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September 2013

FDA: Ge Pharma Recalls Creafuse Lots Due To Hidden Ingredients

The U.S. Food and Drug Administration (FDA) announced that Ge Pharma, LLC is recalling lots of its products due to hidden ingredients.

The two products are Creafuse Powder Grape (lot #GE4568) and Creafuse Powder Fruit Punch (lot #GE4570). The products in these lots contain the hidden ingredient 1,3 dimethylamylamine (DMAA).

DMAA is often used as an ingredient in stimulant, pre-workout, and weight loss dietary supplement products. The FDA warns consumers that DMAA may be potentially dangerous. DMAA may increase blood pressure and cause heart health problems. A number of side effects related to supplements that contain DMAA have been reported to the FDA. The FDA also warns that DMAA is not a dietary ingredient and is not compliant with the Dietary Supplement Health and Education Act (DSHEA).

Creafuse Powder Grape and Creafuse Powder Fruit Punch were distributed nationwide. The products were sold over email and telephone. Both are packaged in a white, 600-gram container marked with an expiration date of February 2015.

The FDA advises consumers who have purchased these affected lot numbers of Creafuse should immediately discontinue use of the product. Consumers should contact their health care professional with any side effects related to the use of these items.

Consumers may also contact GE Pharma LLC directly at 1-203-675-1057, Monday - Friday, 11 a.m. - 5 p.m. EST for further instructions on disposing or returning the product, as well as refunds, credits, and exchanges.

Both health professionals and consumers are encouraged to report any side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

References

  1. Natural Standard: The Authority on Integrative Medicine. 
  2. US Food and Drug Administration. www.fda.gov

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