It took a third warning from the FDA www.fda.gov, but the makers of dietary supplements known as Reumofan Plus and Reumofan Plus Premium issued a recall notice on Feb. 15 after potentially harmful ingredients were found in Reumofan Plus during the FDA’s analysis. Voluntary Recall of Reumofan Plus Tablets
Sold to treat arthritis, muscle pain, osteoporosis, bone cancer and other conditions, the product has also been marketed as “WOW” and possibly under other labels. It comes in 30 tablet containers in a green and gold box. Reumofan Recall Due to Undeclared Drug Ingredients.
Regardless of the label, consumers taking or who have taken the products in the past should take immediate notice of the findings and stop taking the supplement after seeing a health care professional, then file a report with the FDA about “serious side effects or product quality problems.”
Laboratory analysis revealed prescription drug ingredients “including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocrabamol (a muscle relaxant).” These ingredients have the potential to cause serious injury and harmful interaction with other medications, according to the agency, which noted it “has received dozens of adverse event reports, many of them serious.” Consumers who used Reumofan Plus said they have sustained “liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression, stroke, and even death.”
While the company said it is recalling only the single lot of the tablets, the FDA urges consumers to stop taking Reumofan Plus and Reumofan Plus Premium – or any products with Riger Naturals S.A. labeling on the bottom of the bottle. It is important to note that consumers should stop take the product after consulting with a physician, as an abrupt stop to the supplement could cause withdrawal symptoms. FDA Q&A on Reumofan Plus
Until the most recent recall, the FDA said the company had continued to sell the product, manufactured in Mexico, on several websites despite previous warnings in June and August 2012. Its investigation is continuing.
The FDA says “consumers should report serious side effects or product quality problems with the use of these products to FDA’s MedWatch Adverse Event Reporting program. Public Warning – Undeclared Drug Ingredients.
You can also call CaseyGerry’s office if you have concerns about effects you or loved ones may have sustained from using this product. We have the expertise to evaluate your rights to potential compensation and to carry your case forward.