FDA recall D-828-2013

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.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2013-03-11

Report date

2013-08-07

Termination date

2013-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Riverside, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-828-2013