D-930-2013 Class I Terminated
FDA drug recall D-930-2013 was initiated by Beamonstar Products on May 1, 2013 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unappr… The recall status is terminated (terminated April 21, 2014). Affected quantity: 145,632 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- September 11, 2013
- Initiation Date
- May 1, 2013
- Termination Date
- April 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145,632 capsules
Product Description
Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ
Reason for Recall
Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Distribution Pattern
US states nationwide and international.
Code Information
All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563