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Class I: serious health riskTerminated

Y-O Management LLC, dba Natural Remedy Store Natural Remedies Active Male 500 mg Male Recall

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactur…

Y-O Management LLC, dba Natural Remedy Store · San Antonio, TX

Risk level
Class I
Reported by FDA
Apr 8, 2020
Recall ID
D-1080-2020
Check your lot numberHow we source this data

Summary

Y-O Management LLC, dba Natural Remedy Store recalled Natural Remedies Active Male 500 mg Male starting Mar 16, 2020. The FDA classified it as Class I (serious health risk) and published enforcement report D-1080-2020 on Apr 8, 2020. Reason: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

Product description

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501

Lot numbers, UPCs & expiration codes

All lots remaining within expiry.

Where it was sold

Distributed in GA and TX

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-1080-2020
Classification
Class I
Status
Terminated
Recall initiated
Mar 16, 2020
FDA report date
Apr 8, 2020
Quantity
19156 packets estimated distributed
Recall type
Voluntary: Firm initiated
Recalling firm
Y-O Management LLC, dba Natural Remedy Store

Original FDA data

Every field from FDA enforcement report D-1080-2020, exactly as published.

Show all FDA fields
City
San Antonio
State
TX
Status
Terminated
Country
United States
Event ID
85232
Address
713 Sw Military Dr
Code information
All lots remaining within expiry.
Postal code
78221
Report date
Apr 8, 2020
Product type
Drugs
Recall number
D-1080-2020
Classification
Class I
Recalling firm
Y-O Management LLC, dba Natural Remedy Store
Product quantity
19156 packets estimated distributed
Termination date
Nov 10, 2021
Reason for recall
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Voluntary / mandated
Voluntary: Firm initiated
Product description
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501
Distribution pattern
Distributed in GA and TX
Recall initiation date
Mar 16, 2020
Initial firm notification
Press Release
Center classification date
Apr 4, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1080-2020, published Apr 8, 2020. 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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