Atlas Operations, Inc. just announced it is conducting a voluntary nationwide recall of the company’s <"http://www.yourlawyer.com/practice_areas/defective_drugs">dietary supplements for sexual enhancement sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779, and 807, according to the U.S. Food and Drug Administration (FDA).
The recalled 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 FDA that a lab analyses found that products tested from certain batches of the following products 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: 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.
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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
The following dietary supplements sold under the following lot numbersâ€”capsules, all counts and all expiration datesâ€”are involved in the recall:
Lot Number ###-494-##: Aspire One
Lot Number ###-50C-##: Sex Enhancer
Lot Number ###-502B-##: Staminil, Sexual Surge, Love Fuel
Lot Number ###-520A-##: Staminil, Sexual Surge, Love Fuel
Lot Number ###-520-##: Vaxitrol
Lot Number ###-521-##: Love Fuel 2
Lot Number ###-705-##: Erexa, Zenerect, Arousin, 72 Hours, Bulk-Unlabeled, Enhancement, Red Hot Sex, Sexual Surge, Libiplus, Erexx, Tacktol, Amour for Him, Erousa, Rockhard, Staminil, Ezerex, Topviril, Vierect, APL, Clyamax
Lot Number ###-706-##: Love Fuel, Rainbow Rocket, Finally On Demand, Xtremexcite, Whatzup
Lot Number ###-807-##: Depth Charge
The FDA noted that lot numbers may or may not contain dashes and that the lot numbersâ€™ first three and last two digits and letters are insignificant. If a consumer has a product with a different name but the same lot number, he/she is urged to contact Atlas Operations, Inc. for recall instructions. Consumers who have purchased these recalled products to discontinue their use and return them to their place of purchase. Recalled products may also be returned directly to Atlas Operations.
Customers can reach Atlas Operations toll-free at 1-800-466-4444 Monday through Friday from 9:00 am – 5:00 pm Eastern Standard Time for instructions on the return and refund process.
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.