ISSUE: Nano Well-being Health Inc. issued a voluntary recall of Super Arthgold, 500 mg capsules to the consumer level. FDA laboratory analysis has found the product to contain chlorzoxazone, diclofenac and indomethacin, making it an unapproved new drug.
Use of this product containing the undeclared drug ingredients has a reasonable probability of resulting in fatal adverse events in consumers and patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who recently undergone cardiac bypass graft surgery. Consumers would be unaware that the product contains Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (and other ingredients) and may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines. The recall includes the following lots:
lot L1P1-6100/Expiration date June 25, 2016
lot L1P2-6000/Expiration date September 16, 2016
BACKGROUND: The product is used as a dietary supplement for joint pain and arthritis and is packaged in bottles of 120 capsules. The product was distributed nationwide to wholesalers.
RECOMMENDATION: Nano Well-being Health Inc. is notifying its distributors and customers by letter and phone call and is arranging for replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase.
Consumers with questions regarding this recall can contact Nano Well-being Health Inc. by phone at 1-714-515-4600 or e-mail address of at email@example.com, Monday to Friday from 9:00 AM to 5 PM, Pacific Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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.htm
- 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