FDA Recall D-828-2013
Green Planet Inc · Riverside, CA
Class I — life-threatening Terminated 158 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 record
- Recall number
D-828-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2013-03-11
- Classified by FDA Center
- 2013-07-29
- FDA published
- 2013-08-07
- Terminated
- 2013-08-16
- Recalling firm
- Green Planet Inc
- Firm location
- Riverside, CA