Multi-event May 2013 FDA Recall Drug by Beamonstar Products
This Multi-event Class I drug recall was voluntarily initiated by Beamonstar Products on May 1, 2013 for the product Drug. The FDA reported the reason for recall as 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. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-929-2013
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
05-01-2013
09-11-2013
673,851 capsules
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Beamonstar Products
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US states nationwide and international.
04-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
Batch or Lot Expiration Information
Lot# All lots of product distributed and sold from January 2012 to May 7, 2013 SKUs: 626570609490, 827912089028, 626570617877, 626570615316, 626570623588
Recall Number: D-930-2013
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
05-01-2013
09-11-2013
145,632 capsules
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Beamonstar Products
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US states nationwide and international.
04-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563
