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You are here: Home / Food Recalls / FDA Press Releases / Bodee LLC Recalls Zencore Plus, a Product Marketed as a Dietary Supplement

Bodee LLC Recalls Zencore Plus, a Product Marketed as a Dietary Supplement

March 20, 2009 By The FDA 4 Comments

CONTACT: BODEE LLC: (800) 935-0296 HELP@ZENCOREPLUS.COM

BODEE LLC, 2222 AVENUE OF THE STARS, 702E, CENTURY CITY, CA 90067, ANNOUNCED TODAY THAT IT IS CONDUCTING A NATIONWIDE VOLUNTARY RECALL OF ALL THE COMPANY’S SUPPLEMENT PRODUCT SOLD UNDER THE NAME ZENCORE PLUS.

BODEE LLC IS CONDUCTING THIS RECALL AFTER BEING INFORMED BY REPRESENTATIVES OF THE FOOD AND DRUG ADMINISTRATION (FDA) THAT LAB ANALYSIS BY FDA OF ZENCORE PLUS SAMPLES FOUND THE PRODUCT CONTAINS BENZAMIDENAFIL WHICH IS A NEWLY DISCOVERED PDE5 INHIBITOR.  ALTHOUGH DIFFERENT IN STRUCTURE, BENZAMIDENAFIL IS LIKELY TO HAVE THE SAME PHARMACOLOGICAL PROPERTIES AS THE OTHER THREE PDE5 INHIBITORS, SILDENAFIL, TADALAFIL AND VARDENAFIL, WHICH ARE THE ACTIVE INGREDIENTS OF THREE FDA APPROVED DRUGS FOR ERECTILE DYSFUNCTION (ED). ZENCORE PLUS DOES NOT CONTAIN ANY OF THESE THREE ACTIVE INGREDIENTS. THE USE OF ZENCORE PLUS BY AN UNSUSPECTING USER OF ORGANIC NITRATES MAY POSE A LIFE-THREATENING RISK OF SUDDEN AND PROFOUND DROP OF BLOOD PRESSURE DUE TO POTENTIAL INTERACTION BETWEEN BENZAMIDENAFIL AND ORGANIC NITRATES. THE PROBABILITY OF THIS OCCURRENCE IS UNKNOWN; THEREFORE, IT MAY CAUSE A PUBLIC HEALTH RISK WHEN USED AS A DIETARY SUPPLEMENT.

ZENCORE PLUS IS SOLD IN HEALTH FOOD STORES AND BY MAIL ORDER ON INTERNET NATIONWIDE. THE ZENCORE PLUS PRODUCT IS SOLD AS A 2-CAPSULE BLISTER PACK PACKAGED IN A RETAIL BOOKLET WITH FIVE BOOKLETS IN A BOX OR AS A 10-CAPSULE BLISTER PACK IN A RETAIL BOX. THE CAPSULES WERE SUPPLIED BY HI-TECH PHARMACEUTICALS, INC., NORCROSS, GA.

CUSTOMERS WHO HAVE THIS PRODUCT IN THEIR POSSESSION SHOULD STOP USING IT IMMEDIATELY. 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.

CONSUMERS WITH QUESTIONS MAY CONTACT BODEE LLC MONDAY THROUGH FRIDAY 8:00 AM TO 5:00 PM AT (800) 935-0296 OR HELP@ZENCOREPLUS.COM. BODEE LLC 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 PREVENT RECURRENCE OF THESE ISSUES. IT 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. William G. Flickinger says

    June 16, 2009 at 8:22 pm

    Just ordered Zencore Plus and want to know if it is safe to take and has there been a recall on this product by the FDA and the reason why if there has been recalled. Thank You William Flickinger

    Reply
  2. William Flickinger says

    June 17, 2009 at 7:11 pm

    Like for someone from Zencore to send me information on any recall and is the product safe to take. Looking for a good alternative to prescription drugs.

    Reply
  3. MICHAEL GITTELSON says

    December 13, 2009 at 6:25 pm

    I HAVE TAKEN ZENCOREPLUS TWICE. BOTH TIMES, I EXPERIENCED THE WORST DIGESTIVE TRACT DISTRESS , CHILLS, SHACKINESS OR TREMBLING, DIZZINESS,VOMMITING. IT WAS LIKE GETTING SICK FROM ALCHOL WITHOUT BEING DRUNK.(I WASN’T DRINKING EITHER OF THE TWO TIMES I TOOK IT)I HAVE NEVER EXPERIENCED ANY SIDE EFFECTS FROM ANY DRUGS OR FOOD SUPPLIMENTS, EVER. THIS IS VERY SCARY AND DANGEROUS ‘CRAP’THEY ARE “PUSHING” THAT I AM WILLING TO GO OUT-OF MY-WAY TO KEEP OTHERS FROM HAVING THIS EXPERIENCE. ALSO,IT SEEMS THAT THEIR WEB SITE IS NOT OPPERATING THEIR “HELP” SERVICE. HOW CAN I HELP TO “SHUT THEM DOWN” BEFORE SOMEONE DIES FROM TAKING THEIR “POISON” MICHAEL GITTELSON LOS ANGELES,CALIF.310-345-5543

    Reply
  4. karl says

    May 16, 2010 at 4:52 am

    product worked great, long time erections, but, had dizzy feeling, headache, heart rate picked up strongly, effects lasted for 10 hours.

    Reply

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