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.