Samantha Lynn Inc. Is Voluntary Recalling of all lots of Reumofan Plus Tablets Due to Undeclared Drug Ingredients

Date of Recall

2012-08-28

Recall Details

- August 24, 2012 - Los Angeles, CA. Samantha Lynn Inc. is voluntarily recalling Reumofan Plus Tablets to the consumer level due to findings of undeclared drug ingredients.

The Food and Drug Administration (FDA) sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac. Use of this product could result in life-threatening hypersensitivity reactions and anaphylaxis and could cause a temporary and reversible increase in CNS depression. Samantha Lynn Inc. has not received any reports of adverse events related to this recall.

The product is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. The affected Reumofan Plus lots may include the following lot number(s): 99515ex0916 and expires: 2016. The product is marketed in a green bottle containing 30 lavender round tablets and is distributed nationwide via the internet.

If you purchased Reumofan Plus from Samantha Lynn Inc. between Feb 2012 and June 2012, you will receive an email shortly notifying you of your options. If you purchased Reumofan Plus from elsewhere, DO NOT CONTACT Samantha Lynn Inc. Contact your local FDA office. Consumers that have Reumofan Plus should be aware that the product may pose a health risk. Consumers who are taking these products or who have recently stopped taking Reumofan plus should immediately consult a health care professional. Consumers should return the product to place of purchase or discard.

Consumers with questions regarding this recall can contact Samantha Lynn Inc. by email to [email protected] Monday - Friday between 8am to 5pm, Pacific Standard Time. Consumers should contact their physician or healthcare provider if they have any health questions or have experienced any problems that may be related to taking or using this product.

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:www.fda.gov/medwatch/report.htm1
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
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

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