Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients

[Posted 01/14/2014]

AUDIENCE: Consumer, Health Professional

ISSUE: Human Science Foundation is voluntarily recalling all lots of Pro ArthMax 120 count bottle, labeled and sold as a dietary supplement, to the consumer level. The product has been found to contain undeclared active pharmaceutical ingredients (APIs), making it an unapproved new drug. FDA sample analysis tested the product to contain the following APIs: 2.4mg of Chlorzoxazone, 0.78mg of Nefopam, 2.5mg of Diclofenac, 7.7mg of Ibuprofen, 2.1mg of Naproxen, and 1.9mg of Indomethacin.

Use of this product, containing the undeclared drug ingredients listed above, 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 have recently undergone cardiac bypass graft surgery. Consumers would be unaware that the product contains Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (and other ingredients), 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.

BACKGROUND: Pro ArthMax is marketed as a dietary supplement for joint pain and arthritis and is packaged in 120-count tablets per bottle, in a white plastic screw top bottle. Product was distributed to direct consignees in the state of California then further distributed nationwide to retail stores and via internet sales.

RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase.

Human Science Foundation is notifying its distributors and customers by telephone and e-mail and is arranging for return for credit of all recalled products. Consumers with questions regarding this recall can contact Human Science Foundation by email to hsf@hs-foundation.com from Monday through Friday, 10 AM and 4 PM, PST.

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

[01/13/2014 - Press Release - Human Science Foundation]

[Product Photo]