D-828-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2013
- Initiation Date
- March 11, 2013
- Termination Date
- August 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 429,619 capsules
Product Description
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
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.
Distribution Pattern
Nationwide.
Code Information
Lot# B43N032, Exp 10/15