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Class I: serious health riskTerminated

Organic Herbal Supply TORNADO Male Enhancement Herbal Dietary Recall

TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, suppl…

Organic Herbal Supply · Roseville, CA

Risk level
Class I
Reported by FDA
Jul 19, 2017
Recall ID
D-0966-2017
Check your lot numberHow we source this data

Summary

Organic Herbal Supply recalled TORNADO Male Enhancement Herbal Dietary starting Apr 18, 2017. The FDA classified it as Class I (serious health risk) and published enforcement report D-0966-2017 on Jul 19, 2017. Reason: Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

Product description

TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959

Lot numbers, UPCs & expiration codes

All lots and package sizes

Where it was sold

Nationwide via internet

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-0966-2017
Classification
Class I
Status
Terminated
Recall initiated
Apr 18, 2017
FDA report date
Jul 19, 2017
Recall type
Voluntary: Firm initiated
Recalling firm
Organic Herbal Supply

Original FDA data

Every field from FDA enforcement report D-0966-2017, exactly as published.

Show all FDA fields
City
Roseville
State
CA
Status
Terminated
Country
United States
Event ID
77055
Address
8303 Sierra College Blvd Ste 128
Code information
All lots and package sizes
Postal code
95661-9420
Report date
Jul 19, 2017
Product type
Drugs
Recall number
D-0966-2017
Classification
Class I
Recalling firm
Organic Herbal Supply
Termination date
Mar 9, 2018
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Voluntary / mandated
Voluntary: Firm initiated
Product description
TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959
Distribution pattern
Nationwide via internet
Recall initiation date
Apr 18, 2017
Initial firm notification
Press Release
Center classification date
Jul 11, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0966-2017, published Jul 19, 2017. View the source record (openFDA) · FDA enforcement reports

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

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