From the FDA:
Nutraceutical company XYMOGEN in Orlando, Fla., is recalling
artriphen, a product recommended for the support of healthy joint
function, because it contains traces of the undeclared allergens soy and
milk.
People who have an allergy or severe sensitivity to either allergen
run the risk of serious or life-threatening allergic reaction if they
consume this product. Although there have been no reported allergic
reactions or any adverse events in connection with the product to date,
consumers are urged to return this product for a full refund.
XYMOGEN learned that artriphen might contain the two allergens and
immediately discontinued sale of the product. XYMOGEN then had a
third-party laboratory test the product to confirm the presence of the
allergens.
“In the past, our contract manufacturing partners applied labels to
our products, thus the weight of responsibility on what allergens were
or were not declared rested with them as the party handling the raw
materials,” said Brian Blackburn, XYMOGEN’S president and CEO. “Making
the big leap of taking on your own manufacturing dramatically shifts the
weight. As a result, we have been, since day one, stringently verifying
the presence or absence of allergens in raw materials we purchase,
along with bulk items or finished products received from third-party
manufacturers, as part of our due diligence to ensure product safety and
compliance with U.S. Food and Drug Administration regulations.”
XYMOGEN discovered the allergens were not included in the product’s
labeling while preparing to buy artriphen in bulk and then label and
package it for the first time at its new 136,000-square-foot
manufacturing facility and headquarters in Orlando.
“We were afraid the manufacturer had been fraudulently labeling the
product after we received from them our mandatory allergen checklist,
indicating both allergens as present in the formula,” Blackburn said.
“After questioning them on this discovery, we were able to confirm this
was the case and that we had been dealing with a company that was
clearly incompetent of segregating allergenic raw materials and
communicating their presence in customer’s formulas. If it were not for
XYMOGEN’s experienced and diligent team members that handle these
processes, and our overall team’s commitment to the utmost quality, this
serious error may have remained undiscovered.”
The U.S. Food and Drug Administration’s (FDA) regulations on dietary
manufacturing, packaging and distribution require manufactures to
disclose any of eight identified allergens in the labeling and marketing
of products.
In addition to discontinuing the sale of artriphen, XYMOGEN is
phasing out two other products, coolsens™ and dolorox™, provided by the
same company, neither of which has any known safety concerns.
artriphen was available in quantities of either 90 or 180 capsules.
http://www.fda.gov/Safety/Recalls/ucm351313.htm
