Nubreed Nutrition Issues a Voluntary Nationwide Recall of Undisputed, a Product Marketed as a Dietary Supplement Containing Acacia Rigidula

Contact

Consumers

Nubreed Nutrition
[email protected]
1-888-963-8914

Announcement

Nubreed Nutrition, Inc, announced today that it is conducting a voluntary nationwide recall of all lot codes of the company's dietary supplement product sold under the name Undisputed™, which was marketed as a "pre workout powerhouse" and contained Acacia rigidula. Nubreed Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that Acacia rigidula does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.

Undisputed™ was sold to distributors, wholesalers, retail stores and direct to consumers, but was discontinued by Nubreed Nutrition in October 2015. The product was sold in white bottles with a white cap, containing forty (40) powder servings.

Although no illnesses or injuries have been reported to date in connection with this product, consumers who have Undisputed™ in their possession should stop using it immediately. If consumers experience any adverse side effects due to consumption of this product, they should immediately contact a physician. Adverse reactions or quality problems experienced with the use of this product may be reported to Nubreed Nutrition and to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax:

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid, preaddressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm
• Fax: 1-800-FDA-0178.

The Company is advising consumers who have Undisputed™ to return any unused portion to the retail location from which it was purchased or if purchased directly from Nubreed Nutrition to return any unused portion to: Nubreed Nutrition, Inc, 3138 John R. Road, Suite 310 Troy, MI, 48083; Attention: Undisputed Recall. Consumers with questions regarding this recall can contact the company at 1-888-963-8914 Monday through Friday 9 AM to 5 PM, PST, or they may email [email protected]. Consumers who have purchased this product and have medical concerns should consult with their health care providers.

We sincerely regret any inconvenience to consumers. Nubreed Nutrition has taken this voluntary action out of concern for the health and safety of consumers.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).