Green Plant, Inc. is recalling a product sold over the counter as a dietary supplement under the brand name “Night Bullet” because it contains trace amounts of an FDA-approved drug. The finished product contained trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is an FDA-approved active pharmaceutical ingredient used to treat erectile dysfunction (ED), which makes this product an unapproved drug.
The batch lot number of the recalled product is B43N032, the UPC number is 018505122233, and expiration date is 10/2015. It was sold nationwide between October 2012 and March 2013 to wholesalers and samples provided at trade shows.
If you purchased this product, immediately discontinue use. Contact your doctor if you experience any health problems. Return the product to the place of purchase for a refund. Call the company at 877-621-2048 Monday through Friday from 9:00 am to 5:00 pm PT for questions or instructions on the return and refund process. Any adverse effects should be reported to the FDA’s MedWatch Adverse Event Reporting Program.