UPDATED 05/29/2014. Recall expanded to include all lots of the products.
AUDIENCE: Consumer, Health Professional
ISSUE: 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), 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.
BACKGROUND: Eugene Oregon, Inc. has discontinued the distribution of these products and is notifying its distributors by mail of this voluntary recall. Please see Press Release for lot number identification.
RECOMMENDATION: 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 should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products. 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.