Atlas Operations, Inc., is expanding its December 12, 2009, voluntary nationwide recall of "dietary supplements" for sexual enhancement to include Stamin It, Erectzia, and Vigor 100.
These products were sold throughout the United States.
The recall comes after Food and Drug Administration (FDA) that lab analyses found the products contained Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label.
The undeclared ingredient may pose a threat to consumers 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.
The recalled products are in capsule form and may be packaged in blisters, pouches or bottles. All expiration dates of the products are included in this recall.
Complete list of recalled products and lot numbers
• 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-##
Consumers can identify recalled products by the 3 or 4 digit code located in the middle of the lot numbers noted above, where "#" represents any alphanumeric digit. Additionally, the lot numbers may or may not contain dashes.
Atlas says its laboratories have identified that one of the raw ingredients was tainted with Sulfoaildenafil.
Getting refunds
The company urges consumers who have purchased these products to discontinue their use and return to their place of purchase. Products may also be returned directly to Atlas Operations. Customers can call Atlas Operations at 1-800-466-4444 Monday through Friday from 9:00 am - 5:00 pm EST for instructions on the return and refund process.
Atlas says it did not in any way knowingly or intentionally violate the law with regard to the distribution of these products.
Reporting problems
Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail -- MedWatch 5600 Fishers Lane Rockville, MD 20852-978, or by fax -- 1-800-FDA-0178.
FDA has been warning for years that some of the ingredients in such supplements are unsafe.
Nationwide Recall of Sexual Enhancement Products Expanded...