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Monday, April 19, 2010

Atlas Operations, Inc. Expands The Recall Of Sexual Enhancement Products To Include Stamin It, Erectzia, and Vigor 100.

[UPDATED 04/14/2010] Atlas Operations, Inc. notified consumers of an expansion of its December 2009 voluntary nationwide recall of dietary supplements for sexual enhancement to include Stamin It, Erectzia, and Vigor 100. 
[Posted 12/15/2009] Atlas Operations, Inc. and FDA notified consumers of a nationwide recall of the company's dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. FDA lab analyses found that the products tested from certain batches contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making these products unapproved drugs. The active drug ingredient is not listed on the product labels.
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.
Read the company Press Release for a complete list of product names and lot numbers.
The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm1], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms2" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
[04/12/2010 - Press Release3 - Atlas Operations, Inc.]
[12/11/2009 - Press Release4 - Atlas Operations, Inc.]

Former unapproved Drug list
  

Dietary Supplements Sold Under Lot Numbers

Lot Number ###-494-##
Brand Name
Packaging
Expiration Date
Aspire One
Capsules, all counts
All Dates
Lot Number ###-520C-##
Brand Name
Packaging
Expiration Date
Sex Enhancer
Capsules, all counts
All Dates
Lot Number ###-520B-##
Brand Name
Packaging
Expiration Date
Staminil
Capsules, all counts
All Dates
Sexual Surge
Capsules, all counts
All Dates
Love Fuel
Capsules, all counts
All Dates
Lot  Number ###-520A-##
Brand Name
Packaging
Expiration Date
Staminil
Capsules, all counts
All Dates
Sexual Surge
Capsules, all counts
All Dates
Love Fuel
Capsules, all counts
All Dates
Lot Number ###-520-##
Brand Name
Packaging
Expiration Date
Vaxitrol
Capsules, all counts
All Dates
Lot Number ###-521-##
Brand Name
Packaging
Expiration Date
Love Fuel 2
Capsules, all counts
All Dates
Lot Number ###-705-##
Brand Name
Packaging
Expiration Date
Erexa
Capsules, all counts
All Dates
Zenerect
Capsules, all counts
All Dates
Arousin
Capsules, all counts
All Dates
72 Hours
Capsules, all counts
All Dates
Bulk- Unlabeled
Capsules, all counts
All Dates
Enhancement
Capsules, all counts
All Dates
Red Hot Sex
Capsules, all counts
All Dates
Sexual Surge
Capsules, all counts
All Dates
Libiplus
Capsules, all counts
All Dates
Erexxx
Capsules, all counts
All Dates
Tacktol
Capsules, all counts
All Dates
Amour for him
Capsules, all counts
All Dates
Erousa
Capsules, all counts
All Dates
Rockhard
Capsules, all counts
All Dates
Staminil
Capsules, all counts
All Dates
Ezerex
Capsules, all counts
All Dates
Topviril
Capsules, all counts
All Dates
Vierect
Capsules, all counts
All Dates
APL
Capsules, all counts
All Dates
Clyamax
Capsules, all counts
All Dates
Lot Number ###-706-##
Brand Name
Packaging
Expiration Date
Love Fuel
Capsules, all counts
All Dates
Rainbow Rocket
Capsules, all counts
All Dates
Finally On Demand
Capsules, all counts
All Dates
Xtremexcite
Capsules, all counts
All Dates
Whatzup
Capsules, all counts
All Dates
Lot Number ###-807-##
Brand Name
Packaging
Expiration Date
Depth Charge
Capsules, all counts
All Dates

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