Recall -- Firm Press Release
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Eugene Oregon, Inc. Issues Voluntary Nationwide Expansion Of The Recall Of All Lots Of African Black Ant, Black Ant, And Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients
FOR IMMEDIATE RELEASE - May 28, 2014 (Revised from May 5, 2014) Press Release - Eugene Oregon, Inc. of Levittown, Pennsylvania is voluntarily expanding the recall of the following products to the consumer level:
Product Name Lot Number Packaging Packaging Coloring Quantity Per Package African
All lots Small boxes
6 capsules per box, 8 boxes per display
Black Ant All lots Small boxes
/ tins inside
Green 4 capsules per small box, 20 boxes
display unit. Also packaged in 10 tablets
and 10 capsules in a metal tin.
Mojo Risen All lots
Red and white 2 capsules per envelope, 24 envelopes
per display box.
This recall is a revised version of the recall issued on May 5, 2014 and is revised to reflect the recall of ALL LOTS of the recalled products. Misinformation about the Black Ant product codes and packaging description may have been included in the original press release and this information is intended to clarify any ambiguity and expand the recall to all lots of all recalled products.
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.
Sildenafil and tadalafil can pose a threat to consumers because they can 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, and heart disease often take nitrates. To date, Eugene Oregon, Inc. has not received any reports of adverse events related to this recall.
These products are marketed as dietary supplements for sexual enhancement and packaged in tins, envelopes, and/or boxes and were distributed to consumers nationwide at retail stores. 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:
- Complete and submit reporting form online at www.fda.gov/medwatch/report.htm; or
- Mail or fax reporting form. Download form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-1078.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.