FDA recall D-332-2013

Performance Plus Marketing, Inc. · Class I · drug

Product

libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.

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-332-2013