D-337-2013 Class I Terminated
FDA drug recall D-337-2013 was initiated by Performance Plus Marketing, Inc. on December 17, 2012 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs The recall status is terminated (terminated November 14, 2013). Affected quantity: 70,000 capsules..
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- December 17, 2012
- Termination Date
- November 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,000 capsules.
Product Description
Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
Reason for Recall
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Distribution Pattern
Nationwide
Code Information
Lot# 01MJS0712, Exp 07/15.