The company says it recalled Reumofan Plus tablets because they contain undeclared methocarbamol -- because of potential for side-effects, this drug is considered to be a high-risk medication for the elderly -- and diclofenac, which could produce life-threatening injuries.
Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions, the company said. This product -- sold via the company's website at www.painfreebynature.com -- comes in 30-tablet containers and is packaged in a green and gold box.
The recall was initiated after the U.S. Food and Drug Administration discovered the product in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug. Use of this product could result in serious and life-threatening injuries, the FDA said.
Pain Free By Nature did not manufacture the product but did distribute to customers nationwide. Distribution has been terminated by the company.
Consumers that have Reumofan Plus should be aware that the product may pose a serious health risk, the FDA said. Those taking these products or who have recently stopped taking Reumofan Plus should immediately consult a healthcare professional, the FDA advised.
Consumers who have purchased the 30-tablet containers of Reumofan Plus are urged to return all unopened bottles to: Pain Free By Nature, LLC.
Refunds will be mailed immediately following processing, the company said. Those with questions should contact the company at 1-719-235-8864, Monday to Friday, from 10 a.m. to 2 p.m. MST.