Drug product
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
D-828-2013
Product summary
- Firm
- Green Planet Inc
- Event
- Event 64571
- Status
- Terminated
- Classification
- Class I
- Quantity
- 429,619 capsules
- Official record key
drug-enforcement:D-828-2013
Official wording
Reason: 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.
Code information: Lot# B43N032, Exp 10/15
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
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.