Why it was recalled
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.
Product description
Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
Lot numbers, UPCs & expiration codes
Lot# B43N032, Exp 10/15
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-828-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 11, 2013
- FDA report date
- Aug 7, 2013
- Quantity
- 429,619 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Green Planet Inc
Original FDA data
Every field from FDA enforcement report D-828-2013, exactly as published.
Show all FDA fields
- City
- Riverside
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64571
- Address
- 7260 Sycamore Canyon Blvd
- Code information
- Lot# B43N032, Exp 10/15
- Postal code
- 92508-2332
- Report date
- Aug 7, 2013
- Product type
- Drugs
- Recall number
- D-828-2013
- Classification
- Class I
- Recalling firm
- Green Planet Inc
- Product quantity
- 429,619 capsules
- Termination date
- Aug 16, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
- Distribution pattern
- Nationwide.
- Recall initiation date
- Mar 11, 2013
- Initial firm notification
- Press Release
- Center classification date
- Jul 29, 2013