Pharmaceutical Business review

Xymogen recalls dietary supplement Artriphen

The US-based nutraceutical company said people who have an allergy or sensitivity to either allergen run the risk of serious or life-threatening allergic reaction if this product is consumed by them.

Xymogen president and CEO Brian Blackburn said in the past, the company’s contract manufacturing partners applied labels to its products, thus the weight of responsibility on what allergens were or were not declared rested with them as the party handling the raw materials.

"Making the big leap of taking on your own manufacturing dramatically shifts the weight," Blackburn added.

"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."

The US Food and Drug Administration’s (FDA) regulations on dietary manufacturing, packaging and distribution need manufactures to disclose any of eight identified allergens in the labeling and marketing of products.

Xymogen is staging out two other products, coolsens and dolorox neither of which has any safety concerns, in addition to discontinuing the sale of artriphen.

There have been no reported allergic reactions or any adverse events in connection with the product to date, according to Xymogen.
Consumers can return the product for a full refund.