D-344-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2013
- Initiation Date
- July 19, 2013
- Termination Date
- January 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 bottles
Product Description
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 Pattern
Nationwide
Code Information
All lots including 0312-K2, Exp 11/14