Status
Terminated
Drug Enforcement 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.
Classification
Class I
Report Date
August 7, 2013
Termination Date
August 16, 2013
Product Information
- Product description
- Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Green Planet Inc
- Address
-
7260 Sycamore Canyon Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-828-2013
- Event ID
- 64571
- Recall initiation date
- March 11, 2013
- Center classification date
- July 29, 2013
- Code info
- Lot# B43N032, Exp 10/15
- More code info
- —