Status
Terminated
Drug Enforcement D-344-2014
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.
Classification
Class I
Report Date
December 18, 2013
Termination Date
January 23, 2015
Product Information
- 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.
- Product quantity
- 70 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Myson Corporation, Inc.
- Address
-
1329 Oregon Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-344-2014
- Event ID
- 65762
- Recall initiation date
- July 19, 2013
- Center classification date
- December 12, 2013
- Code info
- All lots including 0312-K2, Exp 11/14
- More code info
- —