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 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.
The product 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.
Company is notifying its
distributors and customers by telephone and e-mail and is arranging for
return for credit of all recalled products.
Consumers/distributors/retailers that have product which is being
recalled should stop using and return to place of purchase for credit.
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. 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.
http://www.fda.gov/Safety/Recalls/ucm381494.htm