Atlas Operations Expands Nationwide Recall of Sexual Enhancement Products Marketed as Dietary Supplements

RECALLS, MARKET WITHDRAWALS, & SAFETY ALERTS ARCHIVE FOR RECALLS, MARKET WITHDRAWALS & SAFETY ALERTS ENFORCEMENT REPORTS INDUSTRY GUIDANCE MAJOR PRODUCT RECALLS – 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. ANNOUNCES EXPANSION OF ITS NATIONWIDE VOLUNTARY RECALL OF SPECIFIC LOTS OF SEXUAL ENHANCEMENT PRODUCTS MARKETED AS DIETARY SUPPLEMENTS

COMPANY CONTACT:
DANIEL KINNEY
954-788-1200

FOR IMMEDIATE RELEASE – APRIL 12, 2010 – POMPANO BEACH, FL “ATLAS OPERATIONS, INC. ANNOUNCED TODAY THAT IT IS EXPANDING ITS DECEMBER 12, 2009 VOLUNTARY NATIONWIDE RECALL OF THE COMPANY’S DIETARY SUPPLEMENTS FOR SEXUAL ENHANCEMENT TO INCLUDE STAMIN IT, ERECTZIA, AND VIGOR 100.

THESE PRODUCTS WERE SOLD AS DIETARY SUPPLEMENTS THROUGHOUT THE UNITED STATES. ATLAS OPERATIONS, INC. IS CONDUCTING A VOLUNTARY RECALL AFTER BEING INFORMED BY THE FOOD AND DRUG ADMINISTRATION (FDA) THAT LAB ANALYSES FOUND THAT THE PRODUCTS TO CONTAIN 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 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.

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

PRODUCT

LOT NUMBER*

72 HOURS (ALL STRENGTHS)

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.