AUDIENCE: Consumer, Emergency Medicine
ISSUE: Kingsway Trading Inc. is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, 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.
See the Press Release for product photos.
BACKGROUND: Product was distributed to: MA, NJ, NY, IL, MD, FL, MO, TX, IN, GA, DE, CO, VA, PA, CT, OR, VA, AZ, and through vendors such as oriental herb stores, acupuncture clinics, and Oriental supermarkets. These retail businesses distribute to their individual customers.
The item is packed in a plastic brown bottle with white cap. Each bottle contains 100 Tablets, each tablet is 300mg.
RECOMMENDATION: Consumers who have purchased the product are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at (718) 366-2300, Monday to Friday, 9:00am to 5:00pm.
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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[02/07/2017 - Press Release - Kingsway Trading Inc.]