Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
All lots including 0312-K2, Exp 11/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-344-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 19, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 70 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Myson Corporation, Inc.
Original FDA data
Every field from FDA enforcement report D-344-2014, exactly as published.
Show all FDA fields
- City
- Long Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 65762
- Address
- 1329 Oregon Ave
- Code information
- All lots including 0312-K2, Exp 11/14
- Postal code
- 90813
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-344-2014
- Classification
- Class I
- Recalling firm
- Myson Corporation, Inc.
- Product quantity
- 70 bottles
- Termination date
- Jan 23, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 19, 2013
- Initial firm notification
- Press Release
- Center classification date
- Dec 12, 2013