FDA recall D-337-2013

Performance Plus Marketing, Inc. · Class I · drug

Product

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

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-337-2013