Pain Free by Nature recalls Reumofan Plus Tablets
Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased through their website at www.painfreebynature.com, because they contain undeclared active pharmaceutical ingredients:
methocarbamol 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.
The
recall was initiated after the US Food and Drug Administration
discovered the product was distributed in packaging that didn't
reveal the presence of the active pharmaceutical ingredients, making it
an unapproved drug.
Pain Free By Nature
did not manufacture the product, but did distribute to customers
nationwide. Distribution has been completely terminated by the company.
Consumers
that have Reumofan Plus should be aware 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 tablet containers of Reumofan Plus are urged to return all unopened bottles to; Pain Free By Nature, LLC, Attn: Nilsen, 211 West 11th Street, Harper, KS, 67058. Refunds will be mailed immediately following processing.
Consumers who have purchased the thirty tablet containers of Reumofan Plus are urged to return all unopened bottles to; Pain Free By Nature, LLC, Attn: Nilsen, 211 West 11th Street, Harper, KS, 67058. Refunds will be mailed immediately following processing.
Consumers with questions may contact the company at (719) 235-8864, Monday thru Friday, between 10 a.m. and 2p.m. MST.
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.
No comments:
Post a Comment