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Multiple Products by R Thomas Marketing: Recall - Undeclared Drug Ingredient
AUDIENCE: Consumer
ISSUE: R Thomas Marketing LLC is voluntarily recalling all lots of the following products to the consumer level:
•Black Ant: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules total)
•Herb Viagra: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
•Real Skill: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
•Stree Overlord: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
•Weekend Prince: BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules)
•African Black Ant: BIG BOX (8 small boxes / 6 capsules per box / 48 capsules)
These products were tested by the FDA and found to contain sildenafil, a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. This undeclared active ingredient poses a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
Out of an abundance of caution, R Thomas Marketing is also recalling all lots of various other products previously sold at the consumer level because these products were sourced from the same vendors as the above-mentioned products and may have resulted in similar misbranding or the likelihood for misbranding to occur in the future. See the Press Release for a list of all recalled products.
BACKGROUND: These products were marketed as dietary supplements for male sexual enhancement. The products are packaged in accordance with the respective identifiers listed above. All lots of the specified products sold by R Thomas Marketing via internet sales from September 2013 to present are included in this recall.
RECOMMENDATION: Consumers and retailers that have any of these above mentioned products should stop using and/or distributing this product immediately and arrange return of the products to: Attn: RECALL NOTICE, R Thomas Marketing LLC, 20 Passaic St., Trenton, NJ 08618
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the MedWatch Safety Alert, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm481067.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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