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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Atlas Operations, Inc. Issues a Nationwide Voluntary Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements

 

Contact Person:
Daniel Kinney - 954-788-1200

FOR IMMEDIATE RELEASE – December 11, 2009 – Pompano Beach, FL – Atlas Operations, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements for sexual enhancement sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 & 807.

These products are currently being sold as a dietary supplement throughout the U.S. Atlas Operations, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that a lab analyses found that the products tested from certain batches of the following products Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09  contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products an unapproved drug. The active drug ingredient is not listed on the product label.

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.

 

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

 

**Lot numbers may or may not contain dashes. The first three and last two digits and letters are insignificant.
***If you have a product with a different name but the same lot number please contact Atlas Operations, Inc. for recall instructions.

Our laboratories have identified that one of the raw ingredients was tainted with Sulfoaildenafil.   Atlas Operations takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals.  We take the utmost pride in our products' quality control without compromising our customer's health. 

We urge consumers who have purchased these products to discontinue their use and return to their place of purchase.  You may also return products 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.

It is the position of Atlas Operations, Inc. that we did not in any way knowingly or intentionally violate the law with regard to the distribution of these products.

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, or by fax.  Online:  www.fda.gov/MedWatch/report.htm.  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.

 

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