FDA Recall D-930-2013

Beamonstar Products · Queen Creek, AZ

Class I — life-threatening Terminated 355 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563

Quantity: 145,632 capsules

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

Recall record

Recall number: D-930-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US states nationwide and international.
Recall initiated: 2013-05-01
Classified by FDA Center: 2013-09-05
FDA published: 2013-09-11
Terminated: 2014-04-21
Recalling firm: Beamonstar Products
Firm location: Queen Creek, AZ

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