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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 Black Ant | All lots | Small boxes inside large box | Red, black, and silver | 6 capsules per box, 8 boxes per display unit. |
| Black Ant | All lots | Small boxes / tins inside large box | 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 | Envelopes inside box | 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.
http://www.fda.gov/Safety/Recalls/ucm399144.htm?utm_source=twitterfeed&utm_medium=twitter
