Recall -- Firm Press Release
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Reumofan Plus USA, LLC & Reumofan USA, LLC is Voluntarily Recalling all lots of Reumofan Plus Tablets Due to Undeclared Drug Ingredients
FOR IMMEDIATE RELEASE - Feb. 15, 2013 - SPRINGFIELD, Pa., /PRNewswire/-- Reumofan Plus USA, LLC and Reumofan USA, LLC is recalling "Reumofan Plus" Tablets, Lot# 99515, exp. 09/16, because they contain undeclared active pharmaceutical ingredients: methocarbamol, dexamethasone, and diclofenac. Use of this product could result in serious and life-threatening injuries.
Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. This product comes in thirty (30) tablet containers and is packaged in a green and gold box. Reumofan Plus was distributed nationwide through internet sales.
One illness has been reported to date in connection with this problem.
The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug.
Distribution of the product has been completely terminated by Reumofan Plus USA, LLC and Reumofan USA.
Consumers that have Reumofan Plus should be aware that the product may pose a serious health risk. Consumers who are taking these products or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers who have purchased the thirty (30) tablet containers of Reumofan Plus are urged to return them, to; Reumofan Plus USA, LLC & Reumofan USA, LLC, 737 Buttonwood Drive, Springfield, PA 19064, where they will be exchanged for a new all-natural supplement of herbs only. This product was independently lab-tested to contain only all-natural herbs.
Consumers with questions may contact the company at (610)544-9761, Monday thru Friday, between 10:00 a.m. and 2:00p.m. EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Online: http://www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm.
Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the US Food and Drug Administration.