FDA Recall D-327-2013
Evol Nutrition · Kennesaw, GA
Class I — life-threatening Terminated 333 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351
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 record
- Recall number
D-327-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2012-08-23
- Classified by FDA Center
- 2013-05-16
- FDA published
- 2013-05-22
- Terminated
- 2013-07-22
- Recalling firm
- Evol Nutrition
- Firm location
- Kennesaw, GA