The California based company, Green Planet Inc., announced yesterday in a press release, the voluntary consumer recall of a dietary supplement marketed under the brand name of "Night Bullet," found to contain trace amounts of an FDA-approved drug for erectile dysfunction.
Finished product of Night Bullet was tested by the Food and Drug Administration (FDA) and found to contain trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil. Sulfohydroxyhomosildenafil and Aminotadalafil are an analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED) making this product an unapproved drug.
These undeclared active ingredients pose a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. ED is a common problem in men with these conditions and they may seek products to enhance sexual performance. Additionally sildenafil may cause side effects such as, headaches and flushing. Green Planet has not received any reports of adverse events related to this recall.
Night Bullet is marketed as a supplement for male enhancement. The recalled products are in capsule form, packaged in one (1) count blister packs. The lot and expiration date can be found on the back of the package. The following lot is being recalled, Batch: B43N032, UPC code: 018505122233, and expiration date of 10/2015.
Night Bullet was sold nationwide between October 2012 and March 2013 to wholesalers and sample were also provided at trade shows.
Green Planet is notifying its wholesalers through written correspondence. The FDA urges consumers who have purchased these products to immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking this product. The Company is advising consumers to return the product to their place of purchase. Consumers may also return products directly to Freedom Trading. Customers can call the Company at 877-621-2048 Monday through Friday from 9:00 am – 5:00 pm PST for instructions on the return and refund process.
Any adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
- Online: http://www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the preaddressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.