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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 64571
Product Type Drugs
Status Completed
Recalling Firm Green Planet Inc
City Riverside
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-11
Initial Firm Notification of
Consignee or Public
Press Release
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA Lot# B43N032, Exp 10/15 Class I Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug. 429,619 capsules D-828-2013