Product: 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.
Recall initiated: 20130311
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated