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FDA: Manufacturer recalls Reumofan Plus
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The FDA announced that Samantha Lynn Inc. has voluntarily recalled Reumofan Plus tablets because of undeclared drug ingredients.
A sample analysis by the FDA found that the product, used to treat muscle pain, arthritis, osteoporosis and bone cancer, contained methocarbamol, dexamethasone and diclofenac sodium. Side effects of the analyzed supplement could include life-threatening hypersensitivity reactions, anaphylaxis and temporary, reversible increase in depression, according to an FDA press release. Samantha Lynn has not received reports of any adverse events in relation to the recall, the FDA said.
The product, primarily sold as a natural medicine through the Internet, is marketed in a green bottle with lavender, round tablets. Affected Reumofan Plus lots might include the following numbers: 99515ex0916, with an expiration date of 2016, according to the press release.
The product is manufactured in Mexico by Riger Naturals, according to the release.
Consumers who purchased Reumofan Plus between February 2012 and June 2012 from Samantha Lynn will receive an email notifying them of their options. People who purchased Reumofan Plus elsewhere are asked to contact a local FDA office. Consumers who are taking or recently stopped taking the product should consult a health care professional and return the pills to the place of purchase or discard, according to the FDA.