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You are here: Home / Food Recalls / FDA Press Releases / Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules

Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules

July 29, 2008 By The FDA 5 Comments

CONTACT: DEVINE DISTRIBUTION: 954-418-9510 G & N WORKS: 813 549-4177 RIZE2.COM: 813 549-4177 RIZE2.INFO: 954 418-9510

FOR IMMEDIATE RELEASE — POMPANO BEACH, FL – JULY 28, 2008 – JACK DISTRIBUTION, LLC, 1501 GREEN ROAD UNIT C POMPANO BEACH, FLORIDA 33064 AND ITS WHOLESALE DISTRIBUTORS G & N WORKS, INC., AND DEVINE DISTRIBUTION, INC., ANNOUNCED TODAY THAT THEY ARE CONDUCTING A VOLUNTARY NATIONWIDE RECALL OF ALL LOT NUMBERS OF THE COMPANY’S SUPPLEMENT PRODUCTS SOLD UNDER THE BRAND NAMES RIZE 2 THE OCCASION AND ROSE 4 HER. NEW LOTS OF RIZE 2 AND ROSE 4 HER (NOT SUBJECT TO THIS RECALL) WILL CONTAIN LOT NUMBERS BEGINNING IN “BL”.

JACK DISTRIBUTION, LLC, IS CONDUCTING THIS RECALL AFTER BEING INFORMED BY REPRESENTATIVES OF THE FOOD AND DRUG ADMINISTRATION (FDA) THAT LAB ANALYSIS BY FDA OF RIZE 2 AND ROSE 4 HER SAMPLES OF RANDOM LOTS FOUND THE PRODUCT CONTAINS POTENTIALLY HARMFUL, UNDECLARED INGREDIENTS. FDA ASSERTS THAT ITS CHEMICAL ANALYSIS REVEALED THAT RIZE 2 THE OCCASION AND ROSE 4 HER CONTAIN THIOMETHISOSILDENAFIL, AN ANALOG OF SILDENAFIL, THE ACTIVE INGREDIENT OF A FDA-APPROVED DRUG USED FOR ERECTILE DYSFUNCTION (ED). FDA MAINTAINS THAT THIS INGREDIENT IS CLOSE IN STRUCTURE TO SILDENAFIL AND IS EXPECTED TO POSSESS A SIMILAR PHARMACOLOGICAL AND ADVERSE EVENT PROFILE. THIS UNDECLARED CHEMICAL POSES A POTENTIAL THREAT TO CONSUMERS BECAUSE IT MAY INTERACT WITH NITRATES FOUND IN SOME PRESCRIPTION DRUGS (SUCH AS NITROGLYCERIN) AND MAY LOWER BLOOD PRESSURE TO DANGEROUS LEVELS.

CONSUMERS WITH DIABETES, HIGH BLOOD PRESSURE, HIGH CHOLESTEROL, OR HEART DISEASE OFTEN TAKE NITRATES. ED IS A COMMON PROBLEM IN MEN WITH THESE CONDITIONS, AND CONSUMERS MAY SEEK THESE TYPES OF PRODUCTS TO ENHANCE SEXUAL PERFORMANCE.

CUSTOMERS WHO HAVE THIS PRODUCT IN THEIR POSSESSION SHOULD STOP USING IT IMMEDIATELY AND CONTACT THEIR PHYSICIAN IF THEY HAVE EXPERIENCED ANY PROBLEMS THAT MAY BE RELATED TO TAKING THIS PRODUCT.

ANY ADVERSE EVENTS THAT MAY BE RELATED TO THE USE OF THIS PRODUCT SHOULD BE REPORTED TO THE FDA’S MEDWATCH PROGRAM BY PHONE AT 1-800-FDA-1088 OR BY FAX AT 1-800-FDA-0178 OR BY MAIL AT MEDWATCH, HF-2, FDA, 5600 FISHERS LANE, ROCKVILLE, MD 20852-9787.

THE COMPANY ADVISES THAT ANY UNUSED PORTIONS CAN BE RETURNED TO THE PLACE OF PURCHASE FOR A FULL REFUND OF PURCHASE PRICE. JACK DISTRIBUTION WILL MANUFACTURE NEW LOTS OF THESE PRODUCTS WHICH ARE NOT SUBJECT TO THE RECALL. THOSE LOT NUMBERS WILL BEGIN WITH “BL” AND WILL BEGIN TO BE SOLD SHORTLY.

RIZE 2 AND ROSE 4 HER ARE SOLD IN ADULT STORES, VITAMIN & NUTRITION SHOPS, CONVENIENCE STORES, AND VIA THE INTERNET NATIONWIDE. THE RIZE 2 PRODUCT IS SOLD AS A (SINGLE BLISTER PACK, THREE COUNT BOTTLES, TWELVE COUNT BOTTLES, AND THIRTY COUNT BOTTLES. ROSE 4 HER IS ONLY AVAILABLE IN SINGLE BLISTER PACKS AND THREE COUNT BOTTLES.

THE COMPANY IS TAKING THIS VOLUNTARY ACTION BECAUSE IT IS COMMITTED AND IS ALWAYS CONCERNED WITH THE HEALTH OF PERSONS WHO HAVE CONSUMED THIS PRODUCT. THE COMPANY IS REVIEWING THE PROCEDURES AND POLICIES OF ALL FIRMS INVOLVED WITH THE MANUFACTURE OF THE PRODUCT TO ENSURE THAT THERE WILL BE NO FUTURE ISSUES WITH REGARD TO RIZE 2 AND ROSE 4 HER PILLS COMPOSITION. THE COMPANY IS WORKING CLOSELY WITH THE FDA IN THE RECALL PROCESS AND IS COMMITTED TO THE QUALITY AND INTEGRITY OF ITS PRODUCTS. IT SINCERELY REGRETS ANY INCONVENIENCE TO CONSUMERS AND ITS OTHER CUSTOMERS.

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Filed Under: FDA Press Releases

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.

Comments

  1. LUIS says

    October 29, 2008 at 6:37 pm

    WHAT ABOUT NEW FORMULA OF RIZE CONTAIN LOT NUMBERS BEGINNING IN “BL”.

    Reply
  2. Rize Two Sucks says

    November 24, 2008 at 9:38 pm

    Rize 2 pills are a SCAM! Don’t buy these things, or enzyte or any of that crap.

    Reply
  3. jose leal says

    January 9, 2011 at 3:24 pm

    the new formula does not work i got some from topiny .com and it didn’t work i used it for three years be for and it work find now it sucks.

    Reply
  4. rj says

    March 4, 2011 at 5:15 am

    Use Hard it works as good if not better than the old formula of rize 2! the new rize 2 Does Not Work

    Reply

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