Safety

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.

 

Eugene Oregon, Inc. Issues Voluntary Nationwide Recall of African Black Ant, Black Ant, and Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients

Contact:
Consumer:
(800) 538-3411
 

FOR IMMEDIATE RELEASE - May 5, 2014 - Eugene Oregon, Inc. of Levittown, Pennsylvania is voluntarily recalling the following products at the consumer level: 

Product NameIdentifiable NumberPackagingPackaging ColoringQuantity Per Package
African Black Ant2006-000926Small boxes inside large boxRed, black, and silver6 pills per small box, 8 small boxes per large box. 48 pills total per large box.
Black Ant2006-3627878Small boxes inside large boxGreen4 pills per small box, 20 small boxes per large box. 80 pills total per large box.
Mojo RisenAll lots. No identifiable number on packaging.Envelopes inside boxRed and white2 pills per envelope, 24 envelopes per box. 48 pills total per box.

Eugene Oregon, Inc. is voluntarily conducting this recall because FDA analysis of these products distributed to a third party revealed that the distributed products contained undeclared amounts of the active pharmaceutical ingredients sildenafil and tadalafil—FDA-approved pharmaceutical ingredients used to treat erectile dysfunction. Conclusive testing has not been done to confirm that the recalled products do, in fact, contain sildenafil and/or tadalafil and this recall is being executed as a precautionary measure. To date, Eugene Oregon, Inc. has not received any reports of adverse events related to this recall.

Sildenafil and tadalafil can pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. Nitrates are found in prescription drugs used to treat diabetes, high blood pressure, high cholesterol, and heart disease. Sildenafil and tadalafil can also cause side effects such as headaches and flushing.

Eugene Oregon, Inc. has discontinued the distribution of these products and is notifying its distributors by mail of this voluntary recall. Consumers that possess these products should stop using them immediately and can return the products to Eugene Oregon, Inc., 922 S. Woodbourne Rd. #304, Levittown, PA 19057-1001. Consumers with questions regarding this recall can contact Eugene Oregon, Inc. by telephone at 1-800-538-3411 from Monday through Friday between 9:00 a.m. and 5:00 p.m. EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products. Consumers can report adverse reactions or quality control problems to the FDA’s MedWatch Adverse Event Reporting program as follows:

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

RSS Feed for FDA Recalls Information [what's this?]

Updated May 28, 2014 Press Release

Photo: Product Labels

Recalled Product Photos Are Also Available on FDA's Flickr Photostream

Page Last Updated: 05/28/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.