March 2013 FDA Recall Drug by Green Planet Inc (D-828-2013 - 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.)

This Class I drug recall was voluntarily initiated by Green Planet Inc on March 11, 2013 for the product Drug. The FDA reported the reason for recall as 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.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-828-2013

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.
Initiated
03-11-2013
Reported
08-07-2013
Quantity
429,619 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64571
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Green Planet Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-16-2013
Product Description About Product Description
Full technical description of the product.
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA

Batch or Lot Expiration Information

Lot# B43N032, Exp 10/15