Products found to contain undeclared medicines
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| The United States: Green Planet, Inc. Issues a Voluntary Nationwide Recall of One Lot of "Night Bullet," a Product Marketed as a Dietary Supplement to Support Male Sexual Performance, Due to Undeclared, Potentially Hazardous Active Ingredient Sulfohydroxyhomosildenafil and Aminotadalafil |
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The Food and Drug Administration (FDA) announced that Green Planet, Inc. is conducting a voluntary consumer recall of a product sold as a dietary supplement under the brand name of "Night Bullet," found to contain trace amounts of an analogue of an FDA-approved drug. Analytical tests conducted by FDA of Night Bullet found that the product contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil. Sulfohydroxyhomosildenafil and Aminotadalafil 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 product an unapproved drug. The recalled products are in capsule form, packaged in one (1) count blister packs. The lot (B43N032) and expiration date (10/2015) can be found on the back of the package. Night Bullet was sold nationwide between October 2012 and March 2013 to wholesalers and sample provided at trade shows. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm343216.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, March 12, 2013
Issued at HKT 15:30
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