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Competitive Edge Labs, LLC at: recalls@competitiveedgelabs.com
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March 18, 2011 – Competitive Edge Labs, LLC, Danville, VA announced today that it is conducting a voluntary nationwide
recall of all lots and codes of the company's dietary supplement product “M-DROL.” Competitive Edge Labs is conducting
this voluntary recall after learning that it is the Food and Drug Administration’s (FDA) opinion that the active
ingredient in M-DROL, 2a, 17a di methyl etiocholan 3-one, 17b-ol, does not meet the definition of a dietary ingredient
and therefore it is their opinion that the product is in violation of provisions of the Food, Drug and Cosmetic Act.
The Company is undertaking this voluntary recall in an abundance of caution.
Competitive Edge Labs, LLC, has already ceased manufacture and distribution of the M-DROL product and is notifying all
vendors that the products have been discontinued. Competitive Edge Labs, LLC is requesting that distributors and
retailers stop marketing and selling these products and are notifying them of the recall and the procedure for
return of all M-DROL inventory.
M-DROL had been sold nationwide, both in retail stores and direct to consumers, but has been discontinued by Competitive
Edge Labs. The product was sold in bottles containing ninety (90) capsules and was manufactured for Competitive Edge
Labs, LLC.
Consumers who have this product in their possession should stop using it immediately. If consumers experience any
adverse side effects due to consumption of this product, they should contact a physician right away. Adverse
reactions or quality problems experienced with the use of this product may be reported to Competitive Edge Labs,
LLC or 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, pre-addressed Form FDA 3500 available at
www.fda.gov/MedWatch/getforms.htm or Fax: 1-800-FDA-0178.
The company is advising consumers who have M-Drol in their possession to return any unused portion to the retail
location from which is was purchased or if purchased directly from Competitive Edge Labs, LLC to contact Competitive
Edge Labs, LLC at recalls@competitiveedgelabs.com or 336-791-0356 for return authorization for full refund or credit.
Consumers with questions regarding this recall can contact the company at 1-336-791-0356 Monday through Friday 9 AM
to 5 PM, EST. Consumers who have purchased this product and have medical concerns should consult with their health
care providers.
Competitive Edge Labs, LLC will continue to work to ensure the health and safety of its customers.
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