D-327-2013 Class I Terminated
FDA drug recall D-327-2013 was initiated by Evol Nutrition on August 23, 2012 and is designated Class I. 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 unapp… The recall status is terminated (terminated July 22, 2013). Affected quantity: 1000 blister packs (total both products).
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- August 23, 2012
- Termination Date
- July 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1000 blister packs (total both products)
Product Description
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.
Distribution Pattern
Nationwide
Code Information
All lots, no Expiry