Legal News for Product Liability Attorneys. A recall of sexual enhancement products sold as dietary supplements was expanded to prevent potential health risks.
News for product liability lawyers- The FDA announced an expansion to a product safety recall of sexual enhancement products retailed as dietary supplements due to potential health risks.
Pompano Beach, FL—In an expansion of a December 12, 2009 voluntary recall of dietary supplements for sexual enhancement, manufactured by Pompano Beach, Florida-based Atlas Operations, Inc., the company has added Stamin It, Erectzia, and Vigor 100 supplements to their list of affected products. The U.S. Food and Drug Administration (FDA) http://www.fda.gov announced the product safety recall on Monday, April 12, 2010.
Reports stated the recalled Atlas Operations, Inc.-manufactured sexual enhancement products contain Sulfoaildenafil, which is an analogue of Sildenafil, a drug used to treat male Erectile Dysfunction (ED). Since the FDA was made aware the product contained Sulfoaildenafil, it became considered a new and unapproved product, subsequently prompting the product safety recall. Sulfoaildenafil was not included in on the product label.
According to the FDA, “The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.”
The product names and lot numbers affected by the recall include the following:
72 Hours (all strengths)
###-705-##
###-706-##
Amour Again for Him
###-705-##
Arousin
###-705-##
Clyamax
###-705-##
Depth Charge
###-807-##
##-807-##
Enhancement
###-705-##
###-706-##
Erectzia
###-705-##
##-705-##
Erexa
###-705-##
Ere-xxx by Elite Body
###-705-##
##-705-##
Ere-xxx by Maxi Elit
###-705-##
Erousa
###-705-##
Ezerex
###-705-##
###-706-##
Finally On Demand
###-706-##
Libiplus
###-705-##
###-520A-##
###-520B-##
Love Fuel
###-706-##
###-520A-##
###-520B-##
Rainbow Rocket
###-706-##
Red Hot Sex
###-705-##
Sexual Surge
###-705-##
Stamin It
###-705-##
###-520A-##
###-520B-##
Staminil
###-705-##
###-520A-##
###-520B-##
Tacktol
###-705-##
Topviril
###-705-##
Vaxitrol
###-520-##
###-520A-##
###-520B-##
###-520C-##
Vierect
###-705-##
Vigor 100
###-705-##
Whatz Up Rx
###-706-##
Xtremexcite
###-706-##
Zenerect
###-705-##
###-779-##
The recalled sexual enhancement products were sold as dietary supplements and packaged in blisters, pouches or bottles. All expiration dates are included in the recall. Consumers have been urged to immediately cease use of the recalled supplements and return them to their place of purchase for a full reimbursement. Atlas Operations may be contacted Monday through Friday at (800) 466-4444 from 9 a.m. to 5 p.m. EST for more information concerning the recall.
Legal News Reporter: Sandra Quinlan- Legal News for Product Liability Lawyers