[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 |
No comments:
Post a Comment