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FDA (Drug enforcement)Recalled 2013-05-01closedclass i

Beamonstar Products: 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

Is my product affected?

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

  • UPC 626570613855
  • UPC 626570619055
  • UPC 626570617860
  • UPC 626570617563

Check against the official notice below — it lists the full affected range.

What happened

Beamonstar Products is recalling Velextra All-Natural Herbal Supplement in various packaging sizes, including 1 and 2 capsule blister packs and 4, 10, and 12 capsule bottles manufactured in Queen Creek, Arizona. The supplement was marketed without FDA approval and has been found to contain tadalafil, which is the active ingredient in an FDA-approved medication used to treat erectile dysfunction. The recall affects all lots distributed and sold from January 2012 through May 7, 2013, totaling 145,632 capsules, and was distributed nationwide and internationally.

The affected products can be identified by SKUs 626570613855, 626570619055, 626570617860, or 626570617563. The recall notice does not specify a remedy or recommended course of action for consumers who may have purchased this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: US states nationwide and international. Quantity: 145,632 capsules Lot/code info: All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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