A recall has just been issued for Reumofan Plus Tablets, the U.S. Food & Drug Administration (FDA) just announced. Samantha Lynn Inc., is recalling 500 lots of Reumofan Plus Tablets, at the consumer level, over findings of undeclared drug ingredients. Reumofan Plus Tablets are used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer, and other conditions.
An FDA sample analysis discovered that the Samantha Lynn Inc. Reumofan Plus Tablets contain methocarbamol and diclofenac and determined that use of this product could result in life-threatening hypersensitivity reactions and anaphylaxis and could also cause a temporary and reversible increase in CNS depression. The recalled Reumofan Plus lots may include lot number 99515 ex096 and expiration date 2016; the product is marketed in a green bottle and contains 30 lavender, round tablets and was distributed, nationwide, via the Internet. To date, Samantha Lynn Inc. has not received any reports of adverse events related to this recall.
Consumers who have purchased Reumofan Plus from Samantha Lynn Inc. between February and June 2012 will receive an email, shortly, notifying them of their options, the firm said. Consumers who have purchased Reumofan Plus elsewhere are advised to contact the FDA and not Samantha Lynn Inc. Samantha Lynn Inc. may be reached via email at firstname.lastname@example.org, Monday through Friday, between 8:00 a.m. and 5:00 p.m., Pacific Standard Time (PST).
FDA’s MedWatch Adverse Event Reporting program can be reached online, by regular mail, or by fax: Online at http://www.fda.gov/MedWatch/report.htm1; regular mail by using the postage-paid, pre-addressed Form FDA 3500 available at http://www.fda.gov/MedWatch/getforms.htm2 and mail to the address on the pre-addressed form; or via Fax, toll-free, to 1.800.FDA.0178.
Last week, we wrote that the FDA issued a warning to consumers concerning Reumofan Plus and Reumofan Plus Premium supplements, and that they contain harmful drug ingredients. The FDA indicated that both supplements contain a number of potentially harmful, active pharmaceutical ingredients that are not listed on the products’ labels. The agency also indicated that it has received dozens of additional adverse event reports that have included reports of death and stroke linked to Reumofan Plus since it first issued a warning about the supplement on June 1, 2012. Other reports have been received that include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression (problems with kidney functioning), the FDA said in its warning.
In June, we reported that the FDA issued a warning for Reumofan Plus dietary supplements, again, due to the presence of potentially harmful pharmaceutical ingredients. In that case, the product was manufactured in Mexico by Riger Naturals and was sold in some retail outlets, at flea markets, and on various Internet sites. The FDA received multiple reports of adverse events associated with the use of Reumofan Plus, which included reports of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.