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Bodee LLC announced last week 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.

Benzamidenafil is likely to have the same pharmacological properties as sildenafil, tadalafil and vardenafil, which are the active ingredients of three FDA approved drugs for Erectile Dysfunction (ED): Viagra (Sildenafil), Levitra (Vardenafil) and Cialis (Tadalafil).

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 (such as nitroglycerin.)

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 the internet nationwide. The official Zencore Plus website is still up and displays an apparently active order page where you can get a “Free Supply” by entering your Visa information.

Note: I did not enter my Visa information to see if the order page is still functioning.

Also still found on the internet are numerous pay-per-click ads (at top and left of search results pages) for the product.

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. Hi-Tech offers on its website a number of male sexual performance enhancers under the trade name Stamina-Rx. It is not known if these products contain benzamidenafil.

Consumers with questions may contact Bodee LLC Monday through Friday 8:00 am to 5:00 pm at 800-935-0296 or elp@zencoreplus.com.

Note: To those of you considering Viagra, Levitra or Cialis as an alternative to Zencore Plus, please read the warning labels and other product information carefully. This law firm has received messages from men who claim to have lost their eyesight from the use of these products.

Here is a quote from the official product information for Cialis:

In rare instances, men taking prescription ED tablets (including CIALIS) reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It’s not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including CIALIS and call your doctor right away.

This blog thanks The Californian for helpful information contained in this post.

Posted in: Drug and Medical Device Claims at 4:26 pm