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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
Recall Number D-828-2013
Classification Class I
Code Info Lot# B43N032, Exp 10/15
Product Distributed Qty 429,619 capsules
Reason For Recall 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.

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.