FDA recall D-344-2014

Product

Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.

Reason for recall

Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-07-19

Report date

2013-12-18

Termination date

2015-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Long Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-344-2014