Kingsway Trading Inc. is recalling its Well Balance Xanthium & Siler Combo (Bi Yan Pian) dietary supplement because it contains a hidden drug that has been banned from the U.S. market because it is linked to serious and sometimes fatal cardiovascular events.
The recall affects Brooklyn, New York-based Kingsway’s Well Balance Xanthium & Siler Combo (Bi Yan Pian) supplements in 1.06 ounce (30g) bottles with Batch No. 130401 and Batch No. 150201. The item is packaged in a plastic brown bottle with a white cap. Each bottle contains 100 tablets, each tablet is 300 mg.
The product was distributed to Massachusetts, New Jersey, New York, Illinois, Maryland, Florida, Missouri, Texas, Indiana, Georgia, Delaware, Colorado, Virginia, Pennsylvania, Connecticut, Oregon, Virginia, and Arizona through oriental herb stores, acupuncture clinics, and Oriental supermarkets. No illnesses have been reported to date.
Laboratory testing determined the products in these lots contain Ephedra Herba (ma huang), also known as ephedrine alkaloids, which pose a risk for serious events including heart attacks, strokes, and death.
“These risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent,” the FDA recall notice states.
Consumers who have affected dietary supplements should stop using them immediately and return them to the place of purchase for a full refund. Anyone who experiences serious side effects after taking these supplements should seek medical attention. Any adverse events related to these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.