D-344-2014 Class I Terminated
FDA drug recall D-344-2014 was initiated by Myson Corporation, Inc. on July 19, 2013 and is designated Class I. 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 pharmac… The recall status is terminated (terminated January 23, 2015). Affected quantity: 70 bottles.
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