Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA

FDA recall notice · announced August 7, 2013 · Green Planet

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: Nationwide.
Lot/code information: Lot# B43N032, Exp 10/15
Quantity: 429,619 capsules
Status: Terminated
Products in this recall event:
- Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA (D-828-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.