The company is taking this action due to the possible inclusion of small metal fragments in the final product.
“The fragments were originally discovered in batches of turmeric extract, ” the Salt Lake City, Utah-based company said on Dec. 5, “an ingredient in Protandim that was purchased from a third party supplier.”
Affected products of Protandim — a supplement containing thirty caplets in a cylindrical blue bottle — were distributed in Japan and the United States between July and November 2012, according to LifeVantage. Lot numbers are located on the left side of the product label when looking at the front of the label, directly above the RFID scan bar.
The affected lot numbers are as follows:
|Lot #||Expiration Date|
Protandim combats oxidative stress, according to LifeVantage. And manufacturers claim the product can indirectly increase antioxidant activity by upregulating endogenous antioxidant factors such as the enzymes superoxide dismutase (SOD) and catalase, as well as the tripeptide glutathione. Like all dietary supplements, Protandim has not been evaluated by the U.S. Food and Drug Administration (FDA) and “is not intended to diagnose, treat, cure, or prevent any disease.”
The company has listed affected lot numbers and is contacting affected independent distributors and other customers to notify them of the recall.
“Everyone at LifeVantage is deeply committed to providing the safest, most pure products for our distributor network and customers,” Douglas C. Robinson, President and CEO of LifeVantage, said. “In keeping to that high standard, the Company is offering to replace all bottles of the potentially affected product. We are confident that our network marketing distribution model will allow us to efficiently contact all those affected by this issue.”
Consumers who have received bottles of Protandim from the lot numbers identified are encouraged to cease use of such product. The Company will immediately reach out to potentially affected consumers.
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.