FDA recall D-336-2013

Performance Plus Marketing, Inc. · Class I · drug

Product

Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430;

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

Nationwide

Key facts

Status
Terminated
Initiation date
2012-12-17
Report date
2013-05-22
Termination date
2013-11-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Commerce, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-336-2013