U.S. Food and Drug Administration

 FDA Statement,  Nov 10, 2004

Kingsway Trading Recalls Expellin Extract and Cardio Flex Dietary Herbal Supplements Because of Possible Health Risk

Kingsway Trading Inc. of Brooklyn, NY, is recalling the dietary herbal supplements DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT (CONCENTRATED) and CARDIOFLEX as they contain Aristolochic Acid, and present a serious health risk to consumers. Aristolochic Acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. Products that contain Aristolochic Acid have been associated with several occurrences of kidney failure. The use of Aristolochic Acid containing products has been linked to increased risk of kidney cancer in people who have consumed it.

DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT (CONCENTRATED) and CARDIOFLEX were imported from China, and distributed nationwide to retail stores and acupuncture clinics from May 2000 to the present. DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT (CONCENTRATED) pills are packed in amber plastic bottles with safety caps and packaged into green cardboard boxes with black lettering on the white panel & red line. CARDIOFLEX pills are packed in white plastic bottles with safety caps and packaged into white cardboard boxes with black lettering and pink & blue colored stripes. The plastic bottles are labeled similarly to the outer boxes. All lots are covered in this recall action.

This recall action is the result of notification by the US Food and Drug Administration that the products contain Aristolochic Acid. The company has ceased distribution of these products.

Consumers who have purchased these products should immediately discontinue their use and return them to the place of purchase for a full refund. Consumers with questions may contact the company at (718) 366-2300.

This advisory was prepared by the FDA Office of Public Affairs.