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Class I: serious health riskTerminated

Beamonstar Products Velextra All-Natural Herbal Supplement Recall

Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4,…

Beamonstar Products · Queen Creek, AZ

Risk level
Class I
Reported by FDA
Sep 11, 2013
Recall ID
D-930-2013
Check your lot numberHow we source this data

Summary

Beamonstar Products recalled Velextra All-Natural Herbal Supplement starting May 1, 2013. The FDA classified it as Class I (serious health risk) and published enforcement report D-930-2013 on Sep 11, 2013. Reason: 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. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

US states nationwide and international.

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-930-2013
Classification
Class I
Status
Terminated
Recall initiated
May 1, 2013
FDA report date
Sep 11, 2013
Quantity
145,632 capsules
Recall type
Voluntary: Firm initiated
Recalling firm
Beamonstar Products

Original FDA data

Every field from FDA enforcement report D-930-2013, exactly as published.

Show all FDA fields
City
Queen Creek
State
AZ
Status
Terminated
Country
United States
Event ID
65130
Address
530 E Hunt Hwy
Address (line 2)
Ste 103
Code information
All lots of product distributed and sold from January 2012 to May 7, 2013. SKUs: SKUs 626570613855, 626570619055, 626570617860, 626570617563
Postal code
85243
Report date
Sep 11, 2013
Product type
Drugs
Recall number
D-930-2013
Classification
Class I
Recalling firm
Beamonstar Products
Product quantity
145,632 capsules
Termination date
Apr 21, 2014
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
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
US states nationwide and international.
Recall initiation date
May 1, 2013
Initial firm notification
E-Mail
Center classification date
Sep 5, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-930-2013, published Sep 11, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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