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Night Bullet: Recall - Undeclared Drug Ingredient
ISSUE: Green Planet, Inc. notified the public of a recall of its dietary supplement product Night B‍ullet. Analytical tests conducted by the FDA found that the product contains trace amounts of Su"lfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil.✔ Sildenafil is the active pharmaceutical ingredient in an FDA-approved ↑drug that is used to treat erectile dysfunction (ED), making this produ≠ct an unapproved drug.

These undeclared active ingredients pose a threat to consumer↔s because sildenafil may interact with nitrates found in ₹some prescription drugs (such as nitroglycerin) and lowe©r blood pressure to dangerous levels. Consumers with diabetes, high b★lood pressure, high cholesterol or heart disease often take nitrateβs. ED is a common problem in men with these conditions and they may seek products to enhanc e sexual performance. Sildenafil may also cause side effects such as headaches and f‌lushing.

The following product lot is being recalled: B43N032, UPC code 0α18505122233, Expiration Date 10/2015

BACKGROUND: Night Bullet is marketed as a supplement for male enhancement. The recalled products are in ca∏psule form, packaged in one (1) count blister packs. Ni≈ght Bullet was sold nationwide between October 2012 and March 2013 to w₩holesalers, and samples were provided at trade shows.

RECOMMENDATION: Consumers who have purchased these products should immediately discontinue the∑ir use and contact their physician if they have experienced any problσems that may be related to taking this product. The Company is a×dvising consumers to return the product to their place §of purchase.

Healthcare professionals and patients are encouraged to® report adverse events or side effects related to the use of these products toβ 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, t>hen complete and return to the address on the pre-addressed foεrm, or submit by fax to 1-800-FDA-0178