Status
Terminated
Drug Enforcement D-327-2013
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Classification
Class I
Report Date
May 22, 2013
Termination Date
July 22, 2013
Product Information
- Product description
- Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351
- Product quantity
- 1000 blister packs (total both products)
- Reason for recall
- Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Evol Nutrition
- Address
-
1075 Cobb International Pl NW Ste F
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-327-2013
- Event ID
- 63232
- Recall initiation date
- August 23, 2012
- Center classification date
- May 16, 2013
- Code info
- All lots, no Expiry
- More code info
- —