Bodee LLC, Issues A Voluntary Nationwide Recall of Zencore Plus, a Product Marketed as a Dietary Supplement
The 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. This release pertains to a recall of the over-the-county dietary supplement Zencore Plus, which has been found to contain a PDE5 inhibitor. Users of the product who also take organic nitrate products or may be given nitrate drugs to treat emergency cardiac distress are at risk for life-threatening cardiac side-effects.
FOR IMMEDIATE RELEASE -- Century City, CA – March 11, 2009 - 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 email@example.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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